UNKNOWN DEPUY TIBIAL INSERT
Received Sep 18, 2006 · Event occurred Aug 22, 2006
Report 1818910-2006-02717 · MDR key 763284
Device
Generic name
Total Knee Replacement
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Component(s), worn
- Explanted
- Replace
- Implant, removal of
Patient
81 YR
- Surgical procedure, repeated
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PATIENT WAS REVISED DUE TO POLY WEAR.
Additional Manufacturer Narrative
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE PRODUCT CODE AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. IT WOULD NOT BE UNREASONABLE TO EXPECT SOME WEAR AFTER 10 YEARS OF IMPLANTATION. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.
Remedial action
- Other