NEXGEN STEMMED TIBIAL COMPONENT
Received Dec 15, 2010
Report 1822565-2010-01365 · MDR key 1949042
Device
Product problems
- Device remains implanted
Patient
62 YR
- Pain
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE PT IS IN SEVERE PAIN AND TAKES PAIN MEDS EVERY DAY.
Additional Manufacturer Narrative
INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THERE ARE NO RETURNED PRODUCTS OR X-RAYS AVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. WITHOUT FURTHER INFO ON THE SURGERY AND/OR RETURN OF PRODUCT AND/OR X-RAYS, A PROBABLE CAUSE FOR ALLEGED DEFICIENCY OR PAIN CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.