UNKNOWN DEPUY 35MM ROUND PATELLA
Received Aug 16, 2012 · Event occurred Aug 14, 2012
Report 1818910-2012-18314 · MDR key 2701432
Device
Product problems
- Naturally Worn
Patient
62 YR
- Pain
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS PAIN. POLY WEAR WAS ALSO INDICATED. (LEFT KNEE).
Additional Manufacturer Narrative
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PER THE INITIAL REPORTING, PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE SUPPLIED INFORMATION. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.