NEXGEN STEMMED NONAUGMENTABLE TIBIA
Received Jan 18, 2011 · Event occurred Dec 6, 2010
Report 1822565-2011-00091 · MDR key 1966406
Device
Product problems
- Loose
Patient
70 YR
- Surgical procedure, repeated
Narrative
Additional Manufacturer Narrative
INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO SURGICAL NOTES ARE AVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. WITHOUT FURTHER INFO ON THE SURGERY AND/OR RETURN OF PRODUCT, A PROBABLE CAUSE FOR TIBIAL LOOSENING CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem
IT WAS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE.