UNKNOWN DEPUY/J&J SZ4 8MM TIBIAL INSERT

Description of Event or Problem

PT SUSTAINED A PERIPROSTHETIC FRACTURE IN (B)(6) 2010 AFTER A FALL. LOOSENING AT THE CEMENT/BONE INTERFACE AND OSTEOLYSIS OCCURRED PROGRESSIVELY AFTER THE FALL. POLY WEAR OF THE TIBIAL INSERT WAS ALSO REPORTED.

Additional Manufacturer Narrative

THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE 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 PRODUCT 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

Additional Manufacturer Narrative

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE, HOWEVER, IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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.

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.