BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM - FIXED TIBIAL BASEPLATE

    MDR report key: 1982729 · Received January 14, 2011

    Report

    Report Number
    3005180920-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 13, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK TIBIAL BASEPLATE FIXED CEMENTED - REF 02.07.1204R/LOT 100868: THE QUALITY AND MANUFACTURING DOCUMENTS OF THE TIBIAL BASEPLATE LOT 100868 (15 PIECES PRODUCED) HAVE BEEN REVIEWED: ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. TWELVE PIECES WERE IMPLANTED UP TO NOW (B)(6) AND ONLY THIS CASE WAS REPORTED. THE BATCH RECORDS OF THE CORRELATED PIECES WERE ALSO CHECKED: GMK POSTERO STAB FIXED LINER - REF 02.07.0410PSF/LOT 102007 (25 PIECES PRODUCED/16 ALREADY IMPLANTED) GMK FEMUR POSTERO STAB CEMENTLESS (NOT MARKET IN THE USA) - REF. 02.07.2105R/LOT 091990 (5 PIECES PRODUCTED / 3 ALREADY IMPLANTED) WITHOUT FINDING ANY ANOMALY OR NOT CONFORMING VALUES IN BOTH THE BATCH RECORDS; NO OTHER ADVERSE EVENTS INVOLVING THESE TWO LOTS WERE REC'D UP TO NOW. FURTHER INVESTIGATION WILL BE CARRY OUT TO IDENTIFY A POSSIBLE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS REQUIRED DUE TO THE SINKING OF THE TIBIA BASEPLATE (B)(4) ON THE MEDIA SIDE. THE PT CAME FOR A F/U CONTROL DUE TO PAIN. IN THE PREVIOUS F/U CONTROL, SIX WEEKS AFTER THE PRIMARY SURGERY, THE PT DID NOT FEEL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK TOTAL KNEE SYSTEM - FIXED TIBIAL BASEPLATE TIBIAL BASE PLATE JWH MEDACTA INTERNATIONAL, SA NA 100868

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GMK PSF INSERT - 02.07.0410PSF/ LOT 102007| GMK FEMUR PS CEMENTLESS - 02.07.2105R| (NOT MARKED IN THE USA)