Tuesday, May 12, 2015

Was the DePuy Pinnacle Hip Implant Ever Recalled?

May 12, 2015 - Those with a metal hip implant have likely heard about the recalled Stryker Rejuvenate and ABGII as well as the recalled DePuy ASR. Stryker and DePuy are facing thousands of lawsuits regarding the recalled hip implants (some of the lawsuits have recently been settled). Despite the more than 6,600 lawsuits against DePuy for the Pinnacle hip implant, a recall has not been issued, although DePuy did discontinue the use of a metal liner in mid-2013. Following the removal of the metal liner, Johnson & Johnson and DePuy deemed the Pinnacle a safe hip implant, and even in the face of mounting lawsuits, continue to defend the Pinnacle’s safe design

 

Metal Liner to Blame for Pinnacle Revisions?

According to DePuy, more than 150,000 Pinnacle hip devices were sold since receiving FDA approval in 2001 and “99% of these Pinnacle hip replacement components are still in use today.” Whether this statement is true or not is unknown, however the majority of problems suffered by Pinnacle recipients occurred when it was paired with the Ultima metal liner. Consumers who suffered health issues associated with the Pinnacle would likely not have been required to have a total hip revision, only to have the metal liner removed and replaced with a polyethylene liner. This does not mean these same consumers might not have experienced DePuy Pinnacle hip dangers including DePuy Pinnacle hip metallosis.

 

DePuy Pinnacle Hip Metallosis

When metal rubs against metal, particularly mismatched metals such as titanium and the much harder cobalt and chromium, microscopic metal ions shear away from the device. These particles become embedded in the surrounding hip tissues or travel to the bloodstream. In the hip tissues, the particles can lead to severe inflammation, chronic pain in the hip, thigh and/or groin, deterioration and destruction of bone and tissue, total hip failure and the necessity for revision surgery. Other DePuy Pinnacle hip dangers include metal toxicity which has a large number of very serious, adverse health effects.

 

Johnson & Johnson Maintains Pinnacle Design is Safe

The first Pinnacle lawsuit was decided in favor of the defendant in late 2014. The verdict surprised many who have been following the Pinnacle cases, however Johnson & Johnson provided a vigorous defense for a device they continue to endorse. In fact, J & J claimed at trial that the woman’s many medical issues she says are directly related to her Pinnacle implant were actually the result of surgeon error in the placement of the device.  

 

DePuy’s ASR Design Based on Pinnacle

But what about the Pinnacle design “issue?” After all, the recalled ASR hip device gained FDA approval based on its substantial similarity to the Pinnacle....

 

Pinnacle FDA Adverse Event Reports

There have been over 2,000 adverse event reports sent to the FDA regarding problems experienced with the Pinnacle. It is widely believed however that only 1-10% of those adversely affected by a product or device will notify the FDA.

 

If you have been harmed by a DePuy Pinnacle hip implant, it could be advantageous for you to speak to a DePuy Pinnacle hip lawyer. Even if you have not yet suffered harm from your Pinnacle, you may, in the future; an experienced DePuy Pinnacle hip lawyer can help to ensure your claim is protected.

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