UNKNOWN DEPUY SINGLE PEG ROUND PATELLA

Description of Event or Problem

PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS REPORTED THAT THE PATIENT FELL. IT WAS SUSPECTED THAT THE TIBIA WAS LOOSE PRIOR TO SURGERY. THE SURGEON DISCOVERED THAT ALL THE COMPONENT WAS LOOSE. THERE WAS ALSO SOME POLY WEAR AND OSTEOLYSIS. IT WAS FELT THAT THE FEMORAL COMPONENT WAS OVERSIZED AND POSSIBLY CONTRIBUTED TO THE FALL.

Additional Manufacturer Narrative

THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION 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

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.