ALPHA PE INSERT WITH RIM

Description of Event or Problem

IT IS REPORTED THAT ON (B)(6) 2009 THE PT WAS IMPLANTED WITH ALPA PE INSERT WITH RIM LL/32, FITMORE C6 HIP STEM, ALLOFIT-S ALLOCLASSIC 58/LL, ALPHA PE HOODED INSERT LL/32 AND VERSYS SYSTEM FEMORAL HEAD 32 +0. THE PT WAS PAIN-FREE ONE YEAR POST-OP. IN 2012, THE PT WAS EXPERIENCING MODERATE - TO SEVERE PAIN BUT THE X-RAYS SHOWED NORMAL SIGNS. LABORATORY CONFIRMS THOUGH THAT THERE WERE "DEEP INFECTION (GRAM-POSITIVE FOR COCCI AND COAGULASE, BUT NEGATIVE FOR STAPHYLLOCOCCI)." ON (B)(6) 2012, THE PT UNDERWENT REVISION SURGERY FOR REMOVAL OF ALL COMPONENTS WITHOUT REPLACEMENT. NEW HIP SURGERY IS PLANNED FOR 2013.

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, THE SURGEON HAD COMMENT THAT "THE REASON FOR THIS COMPLICATION IS NOT THE IMPLANTS. THESE KIND OF LATE INFECTIONS ARE "KNOWN" COMPLICATIONS AND PROBABLY OF HAEMATOGENOUS ORIGIN". ALTHOUGH THAT WAS THE DOCTOR'S COMMENT AS SAID TO THE DISTRIBUTOR OF THESE PRODUCTS, THE SURGEON WAS STILL HENCE AT THIS POINT IN TIME, ZIMMER (B)(4) CONSIDER THIS CASE AS REPORTABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).