BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE SIZE 3/12 MM RIGHT

    MDR report key: 5732292 · Received June 17, 2016

    Report

    Report Number
    3005180920-2016-00292
    Event Type
    Injury
    Date Received
    June 17, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 17, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016: THE REVISION SURGERY HAS BEEN PERFORMED AS PLANNED ON (B)(6) 2016. PRE-OPERATIVE X-RAYS AVAILABLE. THE EXPLANTS WILL NOT BE AVAILABLE. ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: JOINT LAXITY FOUND IN A TKA 1,5 YEARS AFTER OPERATION. THIS MAY IN PART BE DUE TO SOME INTERNAL ROTATION OF THE FEMORAL COMPONENT, WHICH ALSO HAS THE EFFECT OF LATERALIZING THE PATELLA. THE REPLACEMENT OF THE INSERT WITH A THICKER ONE WILL HOPEFULLY SOLVE THE LAXITY PROBLEM WITH A SMALL AND MINIMALLY INVASIVE OPERATION, BUT IT MAY NOT SOLVE THE PATELLA ISSUE. THESE ADVERSE FINDINGS WERE NOT CAUSED BY A FAULTY DEVICE. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 133995: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: (B)(6) 2018. 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

    REVISION PLANNED BECAUSE OF JOINT LAXITY AND PATELLA LATERALISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388214 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE SIZE 3/12 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 133995

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention