BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 7832917 · Received August 30, 2018

    Report

    Report Number
    3005180920-2018-00642
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2018. LOT 171961: 109 ITEMS MANUFACTURED AND RELEASED ON 07 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 105 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN ABOUT 6 MONTHS AFTER PRIMARY: THE TIBIAL COMPONENT WAS LOOSE. THE SURGEON REVISED THE PATELLA IMPLANT, TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676123 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 171961 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention