BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    MDR report key: 8522873 · Received April 17, 2019

    Report

    Report Number
    3005180920-2019-00291
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 APRIL 2019: LOT 180947: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 2023-05-16. 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

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO WOULD HAVE NEEDED A REVISION DUE TO PAIN AND SUSPECTED FEMORAL COMPONENT LOOSENING. THE REVISION WAS PERFORMED ON (B)(6) 2019: THE SURGEON REVISED THE FEMORAL COMPONENT (CONFIRMED TO BE LOOSE) AND POLY BUT DID NOT REVISE THE TIBIAL TRAY. THE POLY WAS REVISED ONLY FOR PROPHYLAXIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PRIMARY TKA ON (B)(6) 2015 AND HAD BEEN ALREADY REVISED DUE TO LAXITY ON (B)(6) 2018 (TIBIAL TRAY, FEMORAL COMPONENT AND POLY WERE REVISED - COMPLAINT (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315575 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 180947 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention