BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R

    MDR report key: 7999378 · Received October 24, 2018

    Report

    Report Number
    3005180920-2018-00815
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    March 27, 2017
    Report Date
    October 24, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825880
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 OCTOBER 2018; LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 OCTOBER 2015. EXPIRATION DATE: 2020-10-06 NO A;NOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED # 5 R REFERENCE 02.07.1205R (K090988); LOT 160024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MARCH 2016 EXPIRATION DATE: 2021-02-27; 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

    CEMENT DIDN'T ADHERE TO IMPLANTS. THE TYPE OF CEMENT USED IS PALACOS R. ADDITIONAL COMMENT PERFORMED BY SURGEON: APPARENTLY A SURGEON HAS REVISED TWO OTHER PATIENTS OF MINE OVER THE LAST YEAR OR SO THAT WERE BOTH MEDACTA KNEES. IN BOTH OF THOSE CASES THERE WAS NO ADHERENCE OF CEMENT TO THE METAL COMPONENTS. FROM WHAT I UNDERSTAND, ONE OF THE KNEES WAS REVISED BECAUSE OF MID FLEXION INSTABILITY AND THE OTHER ONE HAD INCOMPETENCE OF THE MEDIAL COLLATERAL LIGAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839549 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 154712 07630030825880

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention