NATURAL-KNEE II TIBIAL INSERT
Received May 10, 2011 · Event occurred Feb 23, 2011
Report 1822565-2011-01140 · MDR key 2092633
Device
Product problems
- Explanted
Patient
Not reported
- Surgical procedure, repeated
- Osteolysis
Narrative
Additional Manufacturer Narrative
INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION FOR IN 2007. THIS CORRECTIVE ACTION INVOLVED ENHANCING THE LABELING FOR THE NATURAL KNEE II KNEE SYSTEM. REFERENCE MDR 1822565-2006-00284 FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. EVALUATION: NO PRODUCT WAS RETURNED. 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.
Description of Event or Problem
IT IS REPORTED THAT THE PATIENT WAS REVISED FOR RADIOGRAPHICALLY PROVEN OSTEOLYTIC LESIONS AT THE TIBIA HEAD.
Remedial action
- Modification/Adjustment