Description of Event or Problem · 1
I FELL AND SLIPPED IN (B) (6) 2008. MY FEMORAL HEAD WAS BROKEN AND I HAD SURGERY ON (B) (6) 2008. THE FOLLOWING MEDICAL DEVICE HAS BEEN USED IN MY HIP JOINT: LOT # 60816008, (B) (4), (B) (4). SINCE THE MEDICAL DEVICE HAS BEEN USED IN MY HIP JOINT, I HAVE GOT SEVERE PAIN AND I SUFFERED A BROKEN HIP REPLACEMENT. THE SURGERY AND THAT MEDICAL DEVICE HAVE RESULTED IN ONGOING ARTHRITIC CHANGES CAUSING PAIN THROUGH THE HIP JOINT. IT SHOULD BE NOTED THAT THE SURGICAL PROCEDURE INVOLVED A ZIMMER BRAND REPLACEMENT, AND ZIMMER HAS ISSUED A NUMBER OF RECALLS RELATIVE TO THE JOINT IN QUESTION. I HAVE BEEN EVALUATED BY DR (B) (6). I HAVE SIGNIFICANT PAIN AND MY DOCTOR HAS RECOGNIZED THAT FUTURE MY JOINT IS SUBJECT TO A FAILURE. PURSUANT TO ANNOUNCEMENT OF FDA THE SAME MEDICAL DEVICE HAS BEEN RECALLED BY FDA ON NOVEMBER 13, 2009 ZIMMER INC. THE RECALL MEDICAL DEVICE THAT FDA HAS ANNOUNCED, IS LOT # 60378581 AND EDI NUMBER AND RER NUMBER ARE THE SAME MEDICAL DEVICE THAT HAS BEEN IMPLANTED IN MY JOINT. ONLY LOT NUMBERS ARE DIFFERENT. ALTHOUGH THE MEDICAL DEVICE THAT HAS BEEN IMPLANTED IN MY JOINT, HAS CREATED SEVERE PAIN AND SUFFERING IN MY JOINT, COULD YOU PLEASE INVESTIGATE WHETHER THE MEDICAL DEVICE THAT HAS BEEN USED IN MY HIP JOINT, IS A RECALL MEDICAL DEVICE? I BELIEVE THAT ZIMMER MIGHT HAVE MADE ERROR ABOUT THE RECALL'S LOT NUMBER. I ANTICIPATE THAT FDA WOULD INVESTIGATE ABOUT LOT NUMBER. I WILL APPRECIATE YOUR RESPONSE. THANKS. (B) (6). DATES OF USE: ALMOST 2 YEARS, (B) (6) 2008--(B) (6) 2010. DIAGNOSIS OR REASON FOR USE: FEMORAL HEAD WAS BROKEN IN FALL & SLIP.