UNKNOWN DEPUY PATELLA
Received Jan 20, 2012 · Event occurred Dec 28, 2011
Report 1818910-2012-01877 · MDR key 2422862
Device
Product problems
- Naturally Worn
Patient
63 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PATIENT KNEE INFECTION BASED THE PROVIDED INFORMATION. PROVIDED INFORMATION STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. 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 AN E-COLI INFECTION. POLY WEAR WAS ALSO REPORTED. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY ON MASSIVE AMOUNTS OF STEROIDS.
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.
Remedial action
- Other