BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 7453566 · Received April 24, 2018

    Report

    Report Number
    3005180920-2018-00263
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    March 28, 2018
    Report Date
    April 24, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 APRIL 2018 LOT 162189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2016. EXPIRATION DATE: 2021-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 INSTABILITY 1 YEAR AND 6 MONTHS AFTER PRIMARY. THE SURGEON DETERMINED THE TIBIA WAS LOOSE. THE SURGEON REVISED THE INSERT AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296510 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 162189 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention