Recently I began receiving reports of complications involving DePuys Synthes Attune knee implant. The implant is one of the company’s most recent ventures, which it markets as having “patented technologies” that improve range of motion and give patients “the confidence of a stable knee replacement.”
My attention was spiked by dozens of reports DePuy has filed in recent months with the Food and Drug Administration documenting premature failures of the Synthes Attune knee system. Reoccurring in the FDA reports were complaints of unusual swelling, instability and loosening, decreased motion, and persistent pain. Almost all of the patients involved in these reports experienced destabilization in the knee replacement and were forced to undergo painful revision surgeries.
I became even more alarmed after speaking with an orthopedic surgeon who told me that in three recent Synthes Attune knee replacements he’d performed, the cement had separated from the tibial plate during the implant surgery. He was able to correct it with more extensive surgery, but suspects that often it doesn’t happen until after surgery has been completed and the patient has begun to heal – which would then require revision surgery to fix or replace the knee implant.
Adding credence to what the orthopedic surgeon related to me is a recent case report in the August issue of the Journal of Orthopedic Case Reports about a previously unpublished complication of polyethylene insert locking mechanism failure in a 10-months-old knee replacement in a 70-year-old woman for whom DePuy Synthes Attune knee implant was used. In this particular case the patient underwent a trivial fall and presented to the same hospital she had her knee replacement done with knee pain and swelling. Doctors at the hospital discovered that the right knee implant was found to be dislocated. During surgery to repair the dislocation, on exposure, polyethylene was found in the postero-lateral corner of the knee. In the case study doctors concluded,
“Disengagement of polyethylene should be considered as a differential diagnosis in patients who present with acute swelling and instability of the knee. Though it’s a rare complication, there is a possibility that design of the implant or its locking mechanism could contribute to dislocations in future.”
Knee replacement is the most common joint replacement surgeries performed. Approximately 600,000 total knee replacement surgeries are performed annually in the U.S., and experts predict that primary knee replacement will increase four-fold by 2030. But with this dramatic increase in knee replacement seems to have come a correlating increase in complications reported in connection with failed implants. Leading manufacturers of knee implants issued over 700 recalls between 2003 and 2013 related to design or construction flaws. Over one-third of those recalls came from DePuy, the second-largest manufacturer of artificial knee and hip implants in the world.
Learning of the alarming number of knee replacement recalls made by DePuy comes as no surprise to me. The company, a subsidiary of Johnson & Johnson, was deeply involved in the metal-on-metal hip replacement recall – the largest medical device failure in history. In recalling their ASR and Pinnacle metal-on-metal hip implant devices DePuy was found to have continued to promote the hip implants long after their own internal reports showed the ASR and Pinnacle devices were not safe. Even after the ASR was recalled in the U.S., the company continued to market it overseas. The pattern of misconduct I witnessed by DePuy and its corporate officers during the hip recalls was shocking in its scope, and I believe this history warrants close scrutiny of how it handles these latest reports of failures with the Synthes Attune knee implant. Throughout DePuy’s history they seem to continue to place profits over safety and have made concerns of corporate liability paramount to patient welfare.
At present reports continue to grow of DePuy Synthes Attune knee replacements – designed to last 10 -15 years – failing within months. In most of these case the only medical solution is for patients to undergo a painful and costly revision surgery to remove the implant and replace it.
While there is no recall yet, I urge patients who have suffered complications from a DePuy’s Synthes Attune Knee Replacement System to contact Saunders & Walker for a free consultation. As failures rise, we will be available to answer any questions and provide you with important information about your Synthes Attune knee implant.
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