BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20704004 · Received November 18, 2024

    Report

    Report Number
    3005180920-2024-00918
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2024 LOT 2010228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2021. EXPIRATION DATE: 2026-01-06. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0021L FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ L (K140826) LOT 1907923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2019. EXPIRATION DATE: 2024-10-23. 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. GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L (K121416) LOT 179643: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2018. EXPIRATION DATE: 2023-04-03. 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. 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

    REVISION FOR ALLERGY AT ABOUT 3 YEARS POST PRIMARY. ANTIALLERGIC DEVICES IMPLANTED SUCCESSFULLY. THE PATIENT WAS SHOWING SIGNS OF A NICKEL SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596005 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2010228 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention