BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    MDR report key: 18648849 · Received February 6, 2024

    Report

    Report Number
    3005180920-2024-00040
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816833
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 FEBRUARY 2024: LOT 2008656: (B)(4) MANUFACTURED AND RELEASED ON 16-APR-2021. EXPIRATION DATE: 2025-09-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 06 FEBRUARY 2024: GMK-REVISION 02.07.1202L FIXED TIBIAL TRAY CEMENTED SIZE 2 L (K090988) LOT 2002923: (B)(4) MANUFACTURED AND RELEASED ON 15-JULY-2020. EXPIRATION DATE: 2025-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SAME PATIENT OF MDR 3005180920-2022-00432. ETHNICITY AND RACE ADDED IN THIS MDR.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT WITH A LOOSE KNEE FEMUR AND OVERSTRETCHED MCL AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND ADDED SOME VARUS ALIGNMENT AND USED SEMI-CONSTRAINED FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT, REVISED THE TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463275 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0217SCF 07630030816833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention