BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 24343902 · Received February 16, 2026

    Report

    Report Number
    3005180920-2026-00092
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896712
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JANUARY 2026 LOT 2013288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MARCH-2021. EXPIRATION DATE: 2026-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LOT 2013288A: (B)(4) ITEM MANUFACTURED AND RELEASED ON 21-FEB-2025. EXPIRATION DATE: 2030-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION A REVISION SURGERY WAS PERFORMED APPROXIMATELY TWO MONTHS AFTER THE IMPLANTATION OF A PARTIAL KNEE ARTHROPLASTY. THE AVAILABLE X-RAY IMAGES SHOW A COLLAPSE OF THE MEDIAL TIBIAL HEMIPLATEAU, WITH SUBSEQUENT DISPLACEMENT OF THE TIBIAL TRAY. THESE RADIOGRAPHIC FINDINGS ARE CONSISTENT WITH AN INSUFFICIENCY FRACTURE OF THE TIBIAL BONE. SUCH A CONDITION MAY BE MULTIFACTORIAL IN ORIGIN. CONTRIBUTING FACTORS MAY INCLUDE WEAKENING OF THE TIBIAL BONE RELATED TO STANDARD SURGICAL BONE PREPARATION, PATIENT-SPECIFIC BONE QUALITY, AND MECHANICAL LOADING DURING THE EARLY REHABILITATION PHASE, INCLUDING POTENTIALLY INCONGRUOUS MOVEMENTS. BASED ON THE AVAILABLE INFORMATION, NO EVIDENCE OF DEVICE MALFUNCTION OR MANUFACTURING DEFECT HAS BEEN IDENTIFIED. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, THE TIBIAL COMPONENT COLLAPSE WAS THE RESULT OF AN INSUFFICIENCY FRACTURE OF THE MEDIAL TIBIAL HEMIPLATEAU POTENTIALLY RELATED TO STANDARD SURGICAL BONE PREPARATION, AND MECHANICAL LOADING DURING EARLY REHABILITATION. NO EVIDENCE SUGGESTS THAT ANY POTENTIAL ISSUE WITH THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AND REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY MANUFACTURING-RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT REPORTED PAIN ASSOCIATED WITH TIBIAL COMPONENT LOOSENING. RADIOGRAPHIC EVALUATION REVEALED A FRACTURE OF THE TIBIAL MEDIAL COMPARTMENT. PATIENT`S BONE QUALITY NORMAL. IT IS LIKELY THAT THE FRACTURE WORSENED DUE TO THE PATIENT WALKING ON THE ALREADY FRACTURED TIBIA WHILE MANAGING PAIN WITH MEDICATION. THE SURGEON CONVERTED THE PARTIAL KNEE ARTHROPLASTY TO A TOTAL KNEE ARTHROPLASTY, AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405103 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO MEDIAL TIBIAL TRAY S2 LM HSX MEDACTA INTERNATIONAL SA 02.18.TF2.LM 2013288A 07630030896712

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention