BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 7968949 · Received October 16, 2018

    Report

    Report Number
    3005180920-2018-00788
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 OCTOBER 2018: LOT 150939: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-03-31. 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. ADDITIONAL COMPONENT REVISED: GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX #3/10 MM L (K121416), LOT 147475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2015. EXPIRATION DATE: 2020-03-31. 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) 2018 THE SURGEON INFORMED US THAT THE PATIENT NEEDED A REVISION ABOUT 3 YEARS AFTER PRIMARY DUE TO KNEE STIFFNESS. THE NEXT DAY HE REMOVED THE TIBIA AND RE-CEMENTED A LARGER TIBIA WITH A STEM. THE LINER WAS REVISED AS WELL. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGEON'S COMMENT REGARDING THE CAUSE OF THE STIFFNESS WAS THAT SHORTLY FOLLOWING THE PRIMARY SURGERY, THE PATIENT'S WIFE PASSED AWAY AND CONSEQUENTLY THE PATIENT REMAINED BED BOUND FOR A LONG PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811951 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 150939 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention