One of the major ortho hip implant manufacturers, Stryker, issued a voluntary FDA recall on two of it’s products on July 6, 2012. Both the Rejuvenate and the ABG II modular-neck stems were recalled due revisions potentially associated with fretting and/or corrosion at or about the modular neck junction.
However, before the voluntary recall Stryker issued a field safety notice in April 2012, which is an urgent warning to doctors and distributors, concerning problems identified with the company’s hip device. Stryker submitted both systems for FDA approval through the 510(k) Pre-Market Notification Process. Through the 510(k) process company’s can forgo FDA mandated clinical trials by proving that their drug or medical device is substantially similar to an existing product which already has FDA approval. Stryker was able to prove that both hip implants were similar to other hip implants which had FDA approval.
What the field safety notice that Stryker sent out before the recall warns that these artificial hips, made from varying combinations of metal, ceramic and polyethylene, are capable of improperly releasing potentially dangerous amounts of metal debris or metal ions into the bodies of hip replacement recipients. According to the notice the biggest problem in these particular hip replacement is different from others in where the problem deals with the articulation of a metal ball and cup, the problem with these implants is mainly the fretting and corrosion of the junction found in the neck of the implants. Fretting and corrosion of this part of the implant can degrade its metal components, placing the patient at risk.
Other complications connected with Stryker hip replacements may include but arenot limited to the following: premature hip system failure, and the need for revision surgery, unexplained hip pain, swelling and inflammation of the surrounding tissue, elevated levels of metal in the body and bloodstream, loosening and dislocation of the implant, and soft tissue reactions to metal debris within the body.
Unfortunately for patients who have begun to show these side effects, the only way to fix them is to have corrective or replacement surgery on the hip implant.
URL Reference:
prnewswire.com/news-releases/seven-more-plaintiffs-sue-stryker-over-defective-hip-implant-devices-169304516.html
mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON155656
