BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 11626621 · Received April 7, 2021

    Report

    Report Number
    3005180920-2021-00270
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23.03.2021: LOT 180377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-MAR-2016. EXPIRATION DATE: 2021-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 5 YEARS AFTER PRIMARY CEMENTED TKA THE TIBIAL BASEPLATE SUBSIDES MEDIALLY, PROBABLY DUE TO A SECONDARY BONE DEGENERATION, AS NO TRAUMATIC EVENTS WERE REPORTED. THIS EVENT SHOULD BE CATEGORIZED AS DISEASE PROGRESSION AND NOT ATTRIBUTED TO A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 4 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO TIBIAL TRAY SUBSIDENCE. ALL IMPLANTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526305 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 02.07.1202R 157583 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention