BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 21033586 · Received December 30, 2024

    Report

    Report Number
    3005180920-2024-01092
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 2, 2024
    Report Date
    December 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895616
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 DECEMBER 2024: LOT 2105460: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2021. EXPIRATION DATE: 2026-05-09. 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. ADDITIONAL COMPONENTS INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 09 DECEMBER 2024: MOTO PARTIAL KNEE 02.18.IF6.09.LM TIBIAL INSERT FIX S6 LM - 9MM (K1620849) LOT 182210: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2018. EXPIRATION DATE: 2023-07-09. 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. BATCH REVIEW PERFORMED ON 09 DECEMBER 2024: MOTO PARTIAL KNEE 02.18.TF6.LM TIBIAL TRAY FIX CEMENTED S6 LM (K162084) LOT 1910828: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2020. EXPIRATION DATE: 2025-03-20. 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. CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730529 MOTO PARTIAL KNEE SYSTEM - MEDIAL ANATOMICAL FEMORAL COMPONENT CEMENTED S5 LM HSX MEDACTA INTERNATIONAL SA 02.18.005LM 2105460 07630030895616

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention