UNKNOWN DEPUY PATELLA

Description of Event or Problem

PATIENT REVISED TO ADDRESS PAIN. REMOVED SCAR TISSUE AND REPLACED TIBIAL INSERT AND PATELLA.

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 DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFORMATION STATES THE SURGEON TOOK DOWN THE SCAR TISSUE AND REPLACED THE POLY AND PATELLA INSERTS. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.