2008 Zimmer Hip Recall: Foreshadow Of Future Metal-on-Metal Hip Problems
Three years after a temporary Zimmer hip recall, skepticism over metal-on-metal hip replacement systems may finally be reaching a climax.
Perhaps if one had a crystal ball back in 2008 we could have predicted that last August, the FDA would request a recall for 93,000 DePuy ASR systems and in May the administration would ask that 21 orthopedic device manufacturers submit post-op performance reports of their metal-on-metal systems that will track the rate of hip implant failure.
Voluntary suspension of sales in 2008 that many called a Zimmer Hip Recall
In July 2008, Zimmer Inc., one of 21 device makers named in the FDA request, recalled 12,000 Durom Cup acetabular components after a report surfaced implicating the device in higher-than-normal rates of failure.
After updating the surgical instructions packaged with the device, Zimmer remarketed the Durom Cup. But by then the damage had been done. Numerous patients experienced hip complications such as loosening, dislocation and component migration.
Zimmer hip lawsuit cases followed
Some were forced to undergo hip revision surgery and many people retained a Zimmer Hip lawyer to file litigation to win compensation for medical costs and pain and suffering. Today, a number of those claims involving a Zimmer hip lawsuit are consolidated in a New Jersey court.
Recent national events may suggest there should have been a permanent Zimmer hip recall in 2008. In fact, it may be that metal-on-metal devices in total never should have made it to the US market.
Zimmer hip metallosis
Although all-metal hip systems may be more robust than systems that include ceramic or plastic components, metal-on-metal is known to cause metallosis – the dispersal of toxic metal particles into the tissue and bloodstream. A Zimmer hip recall involving the Durom Cup may have prevented thousands of cases of metallosis.
A more widespread recall on all metal-on-metal devices would affect millions of hip replacement recipients.
Every year, more than 200,000 hip replacement procedures occur in the United States, with approximately 40,000 involving metal-on-metal devices. As of last December, 175 metal-on-metal components have been cleared by the FDA.
More likely than an all-out recall on metal-on-metal systems would be the phased discontinuation of the devices, which may be underway today. The effort may get a boost when the FDA publishes data reported by orthopedic manufacturers later this year or next.