UNKNOWN JOURNEY UNI KNEE TIB INSERT

Description of Event or Problem

IT WAS REPORTED THAT, 3 YEARS AFTER AN UKR SURGERY WAS PERFORMED WITH A JOURNEY UNI SYSTEM, THE POLYETHILENE INSERT HAS WORN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH ALL THE IMPLANTS WERE RETRIEVED AND THE KNEE WAS REVISED TO A TOTAL KNEE REPLACEMENT. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).

Additional Manufacturer Narrative

H3, H6. THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE PROVIDED X-RAY IMAGES WERE REVIEWED BY THE CLINICAL TEAM AND APPEAR TO SHOW A RIGHT MEDIAL UNI-KNEE WITH A THICK CEMENT MANTLE POSTERIORLY AND TOWARDS THE TIBIAL EMINENCE THERE IS ALSO SOME RADIOLUCENCY UNDER THE FEMORAL COMPONENT ON THE POSTERIOR ASPECT OF THE FEMUR. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, BASED SOLELY ON THE TWO PHOTOCOPIED X-RAY IMAGES PROVIDED, DEFINITIVE CLINICAL FACTORS WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT CANNOT BE DEFINITIVELY CONCLUDED. IT IS UNKNOWN IF THE REPORTED SCRATCHES ON THE POSTERIOR COMPONENTS CONTRIBUTED TO THE REPORTED POLYETHYLENE INSERT WEAR. THE PATIENT IMPACT BEYOND THE REPORTED POLYETHYLENE INSERT WEAR AND UNI-REVISION/CONVERSION TO TOTAL KNEE ARTHROPLASTY COULD NOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. DEVICES SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, INSTRUCTIONS FOR USE, RISK MANAGEMENT FILES AND PRIOR ACTIONS REVIEW COULD NOT BE PERFORMED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE FRICTION OR JOINT TIGHTNESS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.