On January 17th, 2013 the Food and Drug Administration (FDA) Issued a Safety Communication on all Metal-on-metal Hip Implants. This message was directed to both recipients and prospective recipients of metal-on-metal hip replacements as well as orthopedic surgeons.
The safety communication comes almost two years after the May 2011 order for post-market surveillance that ordered 21 manufacturers of metal-on-metal hip implants to study and report back to the agency on the effectiveness of their products. This order came after the FDA received numerous adverse event reports from recipients of various metal-on-metal hip implants made by some of the top manufacturers.
DePuy Orthopedics, a subsidiary of Johnson and Johnson (J & J) got the ball rolling in 2010 when they announced a recall of the Depuy ASR Hip Resurfacing System and the ASR XL Acetabular System due to higher than expected early failure rates. As stated in The Star Tribune, this massive recall included 90,000 products that were sold worldwide. Since then, more than 30 similar products from various manufactures, including Zimmer and Stryker, have been recalled for the same reason.
As the FDA explains in their Metal-on-Metal Hip Implant Communication, the device fails because the metal ball and the metal cup slide against each other during walking or running, corroding the metal from parts where two implant components connect. When the metal corrodes it is released into the body. This can cause the patient to suffer an adverse reaction to metal debris, (ARMD) which includes damage to the bone and/or soft tissue surrounding the implant or the joint. ARMD is can also be referred to as an adverse local tissue reaction (ALTR).
Soft tissue damage can lead to pain or even metallosis, or metal poisoning, which will ultimately require the patient to undergo a difficult revision surgery. ARMD can also cause the device to loosen, which will also mean a revision surgery is needed.