UNKNOWN DEPUY OVAL DOME PATELLA
Received Aug 2, 2013 · Event occurred Jul 22, 2013
Report 1818910-2013-22849 · MDR key 3261098
Device
Generic name
Patella Proshesis
Manufacturer
1818910 Depuy Orthopaedics, Inc.Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Inadequacy of Device Shape and/or Size
- Noise, Audible
Patient
55 YR
- No Information
Narrative
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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.
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS PATELLA CLUNK SYMPTOMS DUE TO AN UNDERSIZED PATELLA. INSTABILITY WAS ALSO REPORTED.
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.