BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 18266627 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00974
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 DECEMBER 2023 LOT 2119406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2022. EXPIRATION DATE: 2027-04-25. 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 01 DECEMBER 2023: GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826) LOT 2202837: 20 ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-04-18. 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.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO LOOSENING OF CEMENTED TIBIAL AND FEMORAL COMPONENTS, AT ABOUT 1 YEAR 4 MONTHS FROM THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197289 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2119406 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention