NEXGEN STEMMED TIBIAL COMPONENT
Received Dec 7, 2010 · Event occurred Nov 10, 2010
Report 1822565-2010-01273 · MDR key 1924224
Device
Product problems
- Loose
- Implant, removal of
Patient
67 YR
- Surgical procedure, repeated
- Osteolysis
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE AND OSTEOLYSIS.
Additional Manufacturer Narrative
INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE REVISION SURGERY OCCURRED APPROX SIX YEARS AFTER IMPLANTATION. X-RAYS WERE NOT RETURNED FOR ANALYSIS. WITHOUT ADD'L INFO, THE CAUSE OF FAILURE COULD NOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, 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.