BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

    MDR report key: 10095417 · Received May 28, 2020

    Report

    Report Number
    3005180920-2020-00296
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 MAY 2020: LOT 1905234: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2019. EXPIRATION DATE: 2024-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED A SUBSIDENCE FROM THE TIBIA-PLATEAU. HE REMOVED THE PLATEAU ON FRIDAY (B)(6) AND IMPLANTED A CEMENT SPACER. NO SIGNS OF INFECTION FOUND. ON (B)(6) (3 MONTHS AFTER PRIMARY SURGERY) A REVISION SURGERY HAS BEEN PERFORMED AND THE FEMORAL (GMK SPHERE) COMPONENT WAS LEFT IN PLACE. TIBIAL TRAY AND INSERT HAVE BEEN REVISED. THEY IMPLANTED A REVISION-TIBIA SIZE: 2L WITH A 10MM WEDGE AND CEMENTED STEM AND THEY USED A SPHERE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561431 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 FIXED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1202L 1905234 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention