NEXGEN STEMMED NONAUGMENTABLE TIBIA
Received Jan 18, 2011 · Event occurred Dec 15, 2010
Report 1822565-2011-00094 · MDR key 1966403
Device
Product problems
- Loose
- Implant, removal of
Patient
58 YR
- Pain
- Surgical procedure, repeated
Narrative
Additional Manufacturer Narrative
INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THERE ARE NO SURGICAL NOTES OR X-RAYS AVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. WITHOUT FURTHER INFO ON THE SURGERY AND/OR RETURN OF PRODUCT, A PROBABLE CAUSE FOR TIBIAL FAILURE CANNOT BE DETERMINED. EVALUATION: MFG RECORDS FOR THE REPORTED DEVICE WAS REVIEWED AND INDICATES THE DEVICE WAS MFG, INSPECTED, AND PACKAGED TO SPECIFICATIONS. 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 IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL BASEPLATE.