UNKNOWN DEPUY LCS 31MM PATELLA
Received May 16, 2013 · Event occurred Apr 25, 2013
Report 1818910-2013-17256 · MDR key 3116080
Device
Generic name
Patella Prosthesis
Manufacturer
1818910 Depuy Orthopaedics, Inc.Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
Patient
58 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 INITIAL REPORTING STATED NO INVESTIGATIONAL INPUTS WERE AVAILABLE; HOWEVER, PATIENT MEDICAL RECORDS WERE PROVIDED. THE INVESTIGATION COULD NOT CONFIRM OR DRAW ANY CONCLUSIONS REGARDING THE REPORTED PATIENT KNEE INFECTION EVENT WITH THE PROVIDED 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS INFECTION.
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.