Description of Event or Problem · 1
ON (B)(6) 2010 I HAD A TOTAL HIP REPLACEMENT DUE TO BALL OF HIP FROM PRIOR RODING SURGERY HAD BECOME WASTED AWAY. A DEPUY SUMMIT SIZE 9 PROXIMAL POROUS HA COATED STEM, A 40 MM + 1.5 OFFSET ARTICUL/EZE HEAD, DEPUY PINNACLE 60 MM MULTIHOLE ACETABULAR CUP WAS INSERTED WITH 60 MM 40 MM METAL LINER. I WENT THROUGH NORMAL REHAB. THIS DEVICE NEVER FELT QUITE RIGHT HOWEVER, MY CONDITION IMPROVED QUITE A BIT. SEVERAL TIMES IN F/U VISITS WITH DR, I MENTIONED THAT IT FELT LIKE THERE WAS MOVEMENT IN JOINT AND THAT ONE TIME IT FELT LIKE IT HAD LOCKED UP. I WAS TOLD A TENDON WAS ADJUSTING AND IT WOULD GO AWAY AT SOME POINT. IN (B)(6) 2010 I STARTED TO HAVE MORE AND MORE PAIN IN JOINT AND GROIN. AT SOME POINT PAIN RETURNED BELOW KNEE THAT I HAD EXPERIENCED PRIOR TO SURGERY. I FINALLY CALLED DR AND ASKED WHAT DEVICE HAD BEEN IMPLANTED AND WAS TOLD THERE WERE NO PROBLEMS WITH DEVICE I HAD BEEN IMPLANTED WITH. THE PAIN LEVEL CONTINUED TO INCREASE AND ON (B)(6) 2011, I WENT INTO (B)(6) CLINIC IN (B)(6) TO BE EVALUATED. MANY X-RAYS WERE TAKEN AND I WAS TOLD I NEEDED REVISION OF OPERATION. THAT DEVICE HAD FAILED. I AM NOW LIVING ON PAIN MEDS AND CRUTCHES AS I MUST TRY AND CONTINUE TO WORK AS I CANNOT FINANCIALLY MISS WORK FOR TIME TO REHAB AFTER SURGERY. I AM NOW IN COMMUNICATION WITH NUMEROUS OTHERS WHO HAVE HAD PINNACLE CUPS THAT FAILED. I UNDERSTAND THAT DEPUY ASR WAS RECALLED ONLY AFTER FOREIGN HEALTH AGENCIES DOCUMENTED FAILURE RATES. I DON'T UNDERSTAND WHY FDA IS NOT IN ACTION ON DEPUY PINNACLE DEVICE AS MANY PEOPLE ARE SUFFERING AND DON'T HAVE INSURANCE OR MONEY TO LAST THRU REHAB AND MUST CONTINUE TO SUFFER BECAUSE THE FDA FAILS TO TAKE ACTION. I GUESS DEPUY/JOHNSON AND JOHNSON MAKE LARGE DONATIONS AT ELECTION TIME. DO YOUR JOB, TAKE ACTION.