BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 21467673 · Received February 26, 2025

    Report

    Report Number
    3005180920-2025-00130
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    February 4, 2025
    Report Date
    February 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895548
    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 10-FEB-2025: LOT 189247: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2019. EXPIRATION DATE: 10-JAN-2024. 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 DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 10-FEB-2025: MOTO PARTIAL KNEE 02.18.IF1.08.RM TIBIAL INSERT FIX S1 RM - 8MM LOT. 177886 (K162084) LOT 177886: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2018. EXPIRATION DATE: 13-MAR-2023. 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. MOTO PARTIAL KNEE 02.18.TF1.RM TIBIAL TRAY FIX CEMENTED S1 RM (K162084) LOT 160679: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2016. EXPIRATION DATE: 29-MAY-2021. 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. 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

    AT ABOUT 3 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM A MOTO KNEE TO A TOTAL KNEE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED THAT SHE LOST 125 POUNDS AND SAID THE KNEE DIDN'T FEEL THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659058 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM HSX MEDACTA INTERNATIONAL SA 02.18.001RM 189247 07630030895548

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention