UNKNOWN DEPUY AGILITY SZ 3 ANKLE INSERT
Received Nov 14, 2012 · Event occurred Oct 17, 2012
Report 1818910-2012-27587 · MDR key 2831527
Device
Product problems
- Naturally Worn
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS SUSPECTED POLY WEAR.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. THE PROVIDED INFORMATION STATES THE POLY INSERT HAS BEEN IMPLANTED APPROXIMATELY 15 YEARS. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
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.