JOURNEY PFJ IMPLANT X-SM LT

Additional Manufacturer Narrative

(B)(4). ONE JOURNEY KNEE IMPLANT (71461010) WAS RECEIVED FOR INVESTIGATION. THE IMPLANT DISPLAYS INDENT AND/OR SCRATCH MARKS TYPICAL FROM THE EXTRACTION PROCEDURE. A SIGNIFICANT AMOUNT OF CEMENT AND REMAINING TRABECULAR STRUCTURES ARE VISIBLE ON THE INFERIOR SIDE OF THE IMPLANT. THE PATELLAR IMPLANT WAS NOT RETURNED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AN EVALUATION PERFORMED BY OUR RESEARCH LAB NOTED SOME SIGNS OF DAMAGE ON THE PERIPHERY OF THE PROXIMAL END OF THE ARTICULATING SURFACE OF THE IMPLANT, WHICH MAY HAVE BEEN CAUSED DURING REVISION. SOME BURNISHING WAS ALSO VISIBLE ON THE EDGES OF THE IMPLANT. CEMENT WAS WELL ADHERED TO THE NON-ARTICULATING SURFACE AND INTERDIGITATED WITH THE HOST BONE. SOME CEMENT WAS LIFTING OFF THE IMPLANT AT ONE END, WHICH MAY HAVE BEEN CAUSED DURING REVISION. SOME CEMENT WAS HANGING OVER THE EDGE OF THE IMPLANT, WHICH MAY HAVE CONTRIBUTED TO PAIN. THE PRIMARY SOURCE OF THE REPORTED CLICKING AND PAIN COULD NOT BE DETERMINED FROM THIS ANALYSIS. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE FURTHER AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND A CLICKING PATELLA.