PFC*SIGMA/OV/DOME PAT 3 PEG, 32
Received Jul 18, 2013 · Event occurred Jul 11, 2013
Report 1818910-2013-21584 · MDR key 3234870
Device
Generic name
Patella Prosthesis
Manufacturer
1818910 Depuy Orthopaedics, Inc.Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Malposition of Device
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS A PATELLA TRACKING ISSUE.
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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INITIAL REPORTING STATED PATIENT X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE 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.