MOTO PARTIAL KNEE SYSTEM - MEDIAL

Additional Manufacturer Narrative

CLINICAL EVALUATION THE PATIENT UNDERWENT REVISION APPROXIMATELY 10 MONTHS AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY BECAUSE OF PAIN ASSOCIATED WITH TIBIAL COMPONENT SUBSIDENCE. BASED ON THE AVAILABLE RADIOGRAPHIC IMAGES, SUBSIDENCE OF THE TIBIAL COMPONENT INTO THE MEDIAL TIBIAL PLATEAU IS EVIDENT AND CONSISTENT. THE UNDERLYING MECHANISM REMAINS UNCERTAIN AND MAY BE MULTIFACTORIAL. POSSIBLE CONTRIBUTING FACTORS INCLUDE ASEPTIC LOOSENING, COMPROMISED BONE QUALITY, BIOMECHANICAL OVERLOAD, OR AN INSUFFICIENCY FRACTURE WITH COLLAPSE OF THE MEDIAL TIBIAL PLATEAU. NO TRAUMATIC EVENT WAS REPORTED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE ROOT CAUSE CANNOT BE DETERMINED, BUT WE DO NOT HAVE ELEMENTS TO SUSPECT A MANUFACTURING DEFECT, DESIGN DEFICIENCY, OR DEVICE MALFUNCTION. BATCH REVIEW PERFORMED ON 06 JULY 2026: LOT 2212243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2022. EXPIRATION DATE: 2027-AUG-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE TIBIAL COMPONENT SUBSIDENCE MAY HAVE RESULTED FROM MULTIFACTORIAL, CASE-SPECIFIC CLINICAL OR BIOMECHANICAL CONDITIONS, POTENTIALLY INCLUDING ASEPTIC LOOSENING, COMPROMISED BONE QUALITY, BIOMECHANICAL OVERLOAD, OR AN INSUFFICIENCY FRACTURE WITH COLLAPSE OF THE MEDIAL TIBIAL PLATEAU. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIALLY RELATED MANUFACTURING ISSUE, AND THERE IS NO INDICATION THAT A DEVICE MALFUNCTION OR DESIGN DEFICIENCY CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

REVISION SURGERY DUE TO A SUBSIDED TIBIA AFTER ABOUT 10 MONTHS FROM PRIMARY. THE SURGEON REVISED THE MOTO IMPLANTS TO GMK-SPHERIKA IMPLANTS AND REVISED THE PATIENT`S NATURAL PATELLA.