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Stryker Rejuvenate Implant Recall Attorney

Stryker Rejuvenate & Stryker ABG II Hip Implant Neck Stem Device

In July 2012, Stryker issued a recall of its Rejuvenate and ABGII hip replacement systems. The implant has been found to be prone to corrosion, joint dislocation, and the release of metal ions which can cause metallosis, tissue inflammation, and necrosis.

More than 30,000 of the Stryker hip systems have been installed worldwide, 20,000 of them in U.S. patients. The failure of the implant has so far led to over 100 lawsuits being filed against Stryker in Bergen, N.j., where the company’s headquarters are located.

stryker-rejuvenate-abg-lawsuitThe Stryker Rejuvenate and ABGII hip prosthesis recall are part one of the more serious medical device failures in recent history. The Stryker Rejuvenate and ABGII hip prosthesis recall are part one of the more serious medical device failures in recent history. Most of the current hip recalls and failures such as the DePuy ASR are metal on metal hips.

The Stryker Rejuvenate does not have a metal interface between the ball and the cup. The Rejuvenate causes an injury similar to the metal on metal hips but the metal debris is caused by micro motion of the metal joints that connect the stem in the femur to the ball in the hip system. The DePuy A.S.R. was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage are also failing at unacceptably high rate.

The DePuy A.S.R. was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage are also failing at unacceptably high rate.

Stryker has advised that anybody who has a Rejuvenate or ABG II implant should undergo regular blood tests and cross-sectional imaging even if they have not experienced any symptoms associated with failure. Stryker also warns that many patients have presented with elevated metal ion levels and adverse local tissue reactions, despite reporting no symptoms that would indicate their hip was failing.

In a recent report in the Palm Beach Post, Boynton Beach orthopedic surgeon Dr. Robert Zann said that of the 400 Stryker joints he implanted, he has already replaced 100 and expects to replace another 100 by the end of the year. That would represent an extraordinary revision rate of 50 percent in a device that was only introduced in 2009.

Dr. Zann also reported that his Stryker revision patients have suffered a number of serious complications, including measurable metal contamination on blood tests, and painful, fluid-filled tumors around the artificial joints.  “If someone comes here, they are on crutches, they have a walker, they can’t function? Something is wrong with that hip. These are human beings, they are suffering, you can’t leave them like that,” he said. “I think about my patients night and day.” (The Palm Beach Post, March 30, 2013)

Some doctors have predicted the failure rate for the Rejuvenate and ABGII hip replacement systems might go as high as 70 percent. That would mean over 20,000 patients with the implant will have to undergo painful revisions, on top of the painful complications they’ve already endured. Revised artificial hips often perform worse than a first prosthetic, because of issues with bone loss and fit.

Stryker’s negligence in the design of these products would seem to suggest that profit, not patient’s safety, was their biggest concern.  Patients, both young and old, often risk having artificial hips implanted for the promise of a better quality of life. With the failure of its metal on metal implants, Stryker has not only shattered that promise, but more often than not – made the patient’s quality of life worse.

Stryker Orthopaedics has recalled two devices that are used with hip implant devices in paitents undergoing hip replacement surgery.

This recall comes on the heels of multiple reports of problems or adverse events related to complications or defects with both the Stryker Rejuvenate Modular Neck Stem as well as the Stryker ABG II Modular Neck Stem. Patients have reported tissue swelling and pain related to both hip implant components. The biotech division of Stryker Corporation based in Hopkinton, Mass has agreed to remove both the Rejuvenate Hip Implant Stem and the ABG II Hip Implant Replacement Stem from the market and discontinue distribution of both devices worldwide.

Adverse events as reported by the FDA related to these hip implant components are being investigated by our firm.

Field Safety Notice RA2012-067 April, 2012 URGENT: Field Safety Notice FSCA identifier: Product Field Action RA2012-067 Type of Action: Field Safety Corrective Action: Description: ABGII Modular Stems and ABGII Modular Necks Rejuvenate Modular Stems and Rejuvenate Modular Necks Catalog #: See attached List Lot Code: All Dear Distributor/ Risk Management/Surgeon: On April XX 2012 Stryker® Orthopaedics initiated a product field action for the products and lot ID referenced above. The intent of this letter is to list all known potential hazards associated with the below noted issue and list the risk mitigation factors associated with the use of the product. Issue: This communication is intended to inform implanting and/or treating surgeons and other healthcare professionals that Stryker has updated the Instructions for Use (IFU) for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction. Potential Hazards 1. Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space. a. Contact between metal ions and tissues and structures during an implant’s service life may result in an Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (metallosis, necrosis, and/or pain). An ALTR may result in the need for revision surgery. b. Patients with a heightened sensitivity to these ions may experience a hypersensitivity/allergic reaction which may result in the need for revision surgery. Page 1 of 3 Field Safety Notice RA2012-067 2. Excessive fretting debris. Fretting may lead to increased metal debris in the joint space (concentration of debris exceeds individual patient threshold) resulting in osteolysis. Osteolysis may be asymptomatic and may result in the need for revision surgery. Note: Stryker has not received any reports of modular neck fracture associated with fretting/corrosion. Risk Mitigation. The Instructions for Use (IFU) for the ABGII Modular and Rejuvenate Modular Systems have been updated to include information on the potential for fretting and/or corrosion at or about modular neck junctions. In addition to listing the above potential hazards, as well as factors which may increase the risk of these hazards to occur, a Product Correction Bulletin, attached, also identifies specific text updates to the IFUs. In order to provide surgeons with additional background on this issue, Stryker commissioned the preparation of a White Paper on this matter, also attached. Our records indicate that you have received the above referenced product(s). It is Stryker’s® responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. Please assist us in meeting our regulatory obligation by: • Ensuring that copies of this FSN are circulated internally to all affected users. • Displaying the notice prominently until all required actions have been completed within the facility. • Completing the attached customer response form to confirm acknowledgement of this notice and disposition of subject devices. Stryker® Orthopaedics maintains its commitment to developing, manufacturing and marketing the highest quality products for surgeons and patients. We apologize for any inconvenience this Field Safety Corrective Action may create and appreciate your cooperation with our request. If you have any further enquiries, please contact your local Sales Representative. Yours Sincerely, Page 2 of 3 Field Safety Notice RA2012-067 STRYKER® ORTHOPAEDICS FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGMENT FORM April XXXX, 2012 SURGEON ADDRESS CITY, STATE ZIP FSCA identifier: Product Field Action RA2012-067 Description: ABGII Modular Stems and ABGII Modular Necks Rejuvenate Modular Stems and Rejuvenate Modular Necks Catalog #: See attached list Lot Code: All Type of Action: Field Safety Corrective Action I have received the notification from Stryker® Orthopaedics dated April XX, 2012 stating that they initiated a Field Safety Corrective Action of the above referenced product.   Surgeon Date (Signature)   Surgeon (Print)   Please fax this signed and dated form to XXXX Page 3 of 3 RA2012-067 Scope of Devices RA2012-067 – scope of devices covered ABG II Modular Components Catalog No. Description 4845-4-101 ABGII. Modular Stem 4845-4-102 ABGII. Modular Stem 4845-4-103 ABGII. Modular Stem 4845-4-104 ABGII. Modular Stem 4845-4-105 ABGII. Modular Stem 4845-4-106 ABGII. Modular Stem 4845-4-107 ABGII. Modular Stem 4845-4-108 ABGII. Modular Stem 4845-4-201 ABGII. Modular Stem 4845-4-202 ABGII. Modular Stem 4845-4-203 ABGII. Modular Stem 4845-4-204 ABGII. Modular Stem 4845-4-205 ABGII. Modular Stem 4845-4-206 ABGII. Modular Stem 4845-4-207 ABGII. Modular Stem 4845-4-208 ABGII. Modular Stem 4845-4-410 ABGII Modular short neck 4845-4-411 ABGII Modular short neck 4845-4-412 ABGII Modular short neck 4845-4-413 ABGII Modular short neck 4845-4-414 ABGII Modular short neck 4845-4-415 ABGII Modular long neck 4845-4-416 ABGII Modular long neck 4845-4-417 ABGII Modular long neck 4845-4-418 ABGII Modular long neck 4845-4-419 ABGII Modular long neck RA2012-067 – scope of devices covered (continued) Rejuvenate Modular Components Catalog No. Description SPT070000S REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 SPT080000S REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 SPT090000S REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 SPT100000S REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10 SPT110000S REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11 SPT120000S REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 12 NLS-301600P LRG TAP PRI MOD NCK 16DEG 30MM NLS-300000B LRG TAP PRI MOD NCK 0DEG 30MM NLS-341600P LRG TAP PRI MOD NCK 16DEG 34MM NLS-340000B LRG TAP PRI MOD NCK 0DEG 34MM NLS-381600P LRG TAP PRI MOD NCK 16DEG 38MM NLS-380000B LRG TAP PRI MOD NCK 0DEG 38MM NLS-421600P LRG TAP PRI MOD NCK 16DEG 42MM NLS-420000B LRG TAP PRI MOD NCK 0DEG 42MM NLV-300800Y LRG TAP PRI MOD NCK 8DEG 30MM NLV-300800G LRG TAP PRI MOD NCK 8DEG 30MM NLV-340800Y LRG TAP PRI MOD NCK 8DEG 34MM Rejuvenate Modular Components NLV-340800G LRG TAP PRI MOD NCK 8DEG 34MM NLV-380800Y LRG TAP PRI MOD NCK 8DEG 38MM NLV-380800G LRG TAP PRI MOD NCK 8DEG 38MM NLV-420800Y LRG TAP PRI MOD NCK 8DEG 42MM NLV-420800G LRG TAP PRI MOD NCK 8DEG 42MM 2 Product Correction Bulletin ABGII Modular and Rejuvenate Modular Hip Systems Orthopaedics April 25, 2012 This Bulletin is intended to inform implanting and/or treating surgeons and other healthcare professionals that Stryker has updated the Instructions for Use (IFU) for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction. Below outlines the potential hazards associated with fretting and/or corrosion, the factors which may increase the risk of the potential hazards, as well as the updated language that will be added to the IFU. Potential Hazards 1. Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space. a. Contact between metal ions and tissues and structures during an implant’s service life may result in an Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (metallosis, necrosis, and/or pain). An ALTR may result in the need for revision surgery. b. Patients with a heightened sensitivity to these ions may experience a hypersensitivity/allergic reaction which may result in the need for revision surgery. 2. Excessive fretting debris. Fretting may lead to increased metal debris in the joint space (concentration of debris exceeds individual patient threshold) resulting in osteolysis. Osteolysis may be asymptomatic and may result in the need for revision surgery. Factors which may increase the risk of the above Potential Hazards Several factors may contribute to increased metal ion and/or metal debris generation. These include, but are not limited to the following: 1. Additional femoral offset. Applying the same load through the head center with additional offsets will result in greater bending moments at the taper junctions. This may result in greater relative motion between the neck and stem at the taper junction.1 Additional weight or excessive patient weight can also contribute to this phenomenon. 2. Solution Chemistry.2,3 The local chemistry around an implant may vary considerably from patient to patient. Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant. Local pH levels may also influence corrosion. 3. Inadequate locking or assembly of the tapers may lead to increased mechanically assisted corrosion (note: this has not been demonstrated in a bench top setting). 4. Inadequate cleaning of the neck taper may lead to increased debris generation. Risk Mitigation The Instructions for Use (IFU) for the ABGII Modular and Rejuvenate Modular Systems have been updated to include the following information on the potential for fretting and/or corrosion at or about modular neck junctions: WARNINGS • Patient post-operative pain. Inherent to all joint replacement is the risk that a patient will develop post-operative pain; pain is a commonly reported symptom regardless of the device implanted. The clinical literature reveals numerous potential causes of pain not directly related to the implant performance including, but not limited to, prior history of trauma and natural disease progression. For patients who present with pain following implantation with a modular stem containing a modular junction, physicians should consider potential causes of the symptoms, including common sources of pain identified in the clinical literature, for example infection and soft tissue impingement. Causes of pain which are less frequently reported in the literature, including pain related to wear and/or corrosion, should not be discounted. Accurate diagnosis of the source of pain and directed, timely intervention is essential to ensuring effective treatment of pain • Modular Junctions: Mate modular components firmly to prevent dissociation. Machined taper surfaces must be clean, dry and firmly mated to ensure proper seating and assembly. Repeated assembly/disassembly or failure to clean, dry and firmly mate the components could compromise the taper lock and potentially lead to fretting/corrosion. ADVERSE EFFECTS • Corrosion and/or wear at junction of metal implants. Corrosion and/or wear may occur whenever two metal surfaces are in contact. The literature identifies a small number of cases involving wear-related corrosion at modular junctions formed by modular heads (neck/head interface) and modular necks (neck/stem interface). Local joint chemistry and/or other patient-specific conditions such as diabetes or infection may affect the potential for in vivo corrosion. A modular junction may release metal debris and may be affected by duration of service life and the forces acting on the modular junction. A small number of cases report corrosion at modular junctions and/or corrosion of wear-related debris in the implant vicinity, resulting in adverse local soft tissue reactions and potentially, increased metal ion levels in the blood and/or urine. Affected patients may present with symptoms similar to those associated with infection, including pain (most likely during weight-bearing) and swelling at the local joint site. Corrosion and/or wear at the modular junction may result in early revision surgery. Patients with a heightened sensitivity to these ions may experience a hypersensitivity/allergic reaction which may result in the need for revision surgery. References 1. Brown, Stanley et. al, Effects of Neck Extension, Coverage, and Frequency on the Fretting and Corrosion of Modular THR Bore and Cone Interface, Modularity of Orthopedic Implants, ASTM STP 1301, American Society for Testing and Materials, 1997. 2. Messer RL, Tackas G, Mickalonis J, Brown Y, Lewis JB, Wataha JC. Corrosion of machined titanium dental implants under inflammatory conditions. J Biomed Mater Res B Appl Biomater. 2009 Feb;88(2):474-81. 3. Katharine Merritt, Stanley A. Brown. Effect of proteins and pH on fretting corrosion and metal ion release. Journal of Biomedical Materials Research Volume 22, Issue 2, pages 111–120, February 1988.

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Saunders & Walker
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Phone: (727) 579-4500
Phone: 1-800-748-7115

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