J&J DePuy’s Pinnacle total hip implant complaints are mounting up

DePuy Pinnacle Hip Implant Complaints Mount    (NewsInferno)

The FDA has been receiving a growing number of Adverse Event Reports (AERS) involving the all-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant. According to a recent review of its AERS database, 709 Pinnacle Hip Implant AERs were reported in the last three months (July-September.) Of these, 201 relate to Pinnacle Hip Implants with a metal-on-metal liner.

This brings the total number of Pinnacle Hip Implant AERs made to the FDA this year to 1,266 (450 confirmed metal). If this trend continues, DePuy is on track to have over 1,700 Pinnacle AERs (with more than 600 confirmed metal).

In comparison, in all of 2010, the DePuy Pinnacle Hip Implant was named in 557 Pinnacle AERs (271 confirmed metal). In 2009, just 315 (135 confirmed metal) AERs were made involving the Pinnacle Hip Implant.

To put this in perspective, another DePuy artificial hip, the ASR hip implant, had been the subject of 1,195 AERs by August 2010, when it was recalled because of an unexpectedly high early failure rate.

DePuy Pinnacle Hip Implants with polyurethane and ceramic liners have not been named in nearly as many ASRs. Only one of the 709 AERs in the last three months was identified a polyethylene liner. In the last decade, only six AERs have identified a polyethylene liner (one in 2006, two in 2010, and three in 2011.) In the same period, only one identified a ceramic liner (in 2011.)

The metal version of the DePuy Pinnacle Hip Implant has been named in scores of personal injury lawsuit, many of which are now pending in a multidistrict litigation in federal court in Texas. The lawsuits allege that the all-metal version of the best-selling hip implant is similar in design to the recalled DePuy ASR hip implant. Many of the injuries described in the Pinnacle complaints share similarities with DePuy ASR complications, and plaintiffs assert the all-metal Pinnacle device should have been subject to its own recall.

Concerns have been growing for some time that these and other metal-on-metal hip implant devices may shed small metal particles as components rub against each other. This can cause tissue breakdown, bone loss, and the formation of non-cancerous tumors. The shedding of metal shavings can also cause cobalt poisoning, a disorder that, if left untreated, can put patients at risk of tinnitus (ringing in the ears), vertigo, deafness, blindness, optic nerve atrophy, convulsions, headaches, peripheral neuropathy, cardiomyopathy, and hypothyroidism. Some patients with metal-on-metal hip implants may develop an inflammatory reaction known as metallosis.

Plaintiffs’ attorneys expect to see more Pinnacle Hip Implant lawsuit filings in the coming months, and some believe their numbers could come to rival those filed over the DePuy ASR hip implant. The Pinnacle device was on the market years before the DePuy’s ASR implant was introduced, and according to a recent Reuters report, sales for all version of the Pinnacle device outpaced those of the ASR.