BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 12567232 · Received October 4, 2021

    Report

    Report Number
    3005180920-2021-00793
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 4, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20.SEPT.2021: LOT 182912: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-OCT-2018. EXPIRATION DATE: 2023-SEPT-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0510CRR TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R (K181635) LOT. 188616 LOT 188616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-FEB-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0026R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R (K140826) LOT. 2001666 LOT 2001666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2020. EXPIRATION DATE: 2025-APR-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 2.5 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN. AFTER GETTING A CELL COUNT, IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTION. WHEN THE PATIENT WAS OPENED UP, IT WAS DETERMINED THAT THE IMPLANTS WERE LOOSE, AND THE SURGEON DECIDED TO REMOVE ALL THE IMPLANTS AND IMPLANT A LOW FRICTION SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ITS NOT POSSIBLE TO DETERMINE IF THE INFECTION AND IMPLANT LOOSENING ARE SEPARATE OR LINKED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469195 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205R 182912 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention