UNKNOWN DEPUY 14X75 STEM
Received Mar 22, 2012 · Event occurred Feb 21, 2012
Report 1818910-2012-06815 · MDR key 2499408
Device
Product problems
- Loss of or Failure to Bond
Patient
64 YR
- Osteolysis
Narrative
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 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.
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE AND LOOSENING. OSTEOLYSIS WAS DISCOVERED INTRAOPERATIVELY.