UNKNOWN DEPUY LCS TIBIAL INSERT
Received Apr 13, 2012 · Event occurred Mar 20, 2012
Report 1818910-2012-10038 · MDR key 2535547
Device
Product problems
- Loose or Intermittent Connection
- Migration or Expulsion of Device
Patient
69 YR
- Osteolysis
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS MEDIAL COLLAPSE AND LOOSENING OF THE TIBIAL TRAY. OSTEOLYSIS WAS ALSO REPORTED. (RIGHT KNEE).
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 CUSTOMER REPORTS THE PATIENT WAS REVISED TO ADDRESS MEDIAL COLLAPSE AND LOOSENING OF THE TIBIAL TRAY. OSTEOLYSIS WAS ALSO REPORTED. DOI 15 YRS AGO - DOR (B)(6) 2012 (RIGHT KNEE). THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODES AND LOT CODES REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCTS TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.