BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT

    MDR report key: 7052115 · Received November 22, 2017

    Report

    Report Number
    3005180920-2017-00684
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2017. LOT 140350: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2014; EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT. ON 03 NOVEMBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: INSERT REVISION IN TKA 2 YEARS AND 7 MONTHS AFTER PRIMARY FOR JOINT INSTABILITY. THE INSERT WAS EXCHANGED TO A THICKER ONE. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. THIS IS NOT A PROBLEM DUE TO ANY IMPLANT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT COMPLAINED AROUND INSTABILITY AND PAIN, UPON SURGEON EXAMINATION DISCOVERED UNSTABLE ON BOTH MEDIAL AND LATERAL SIDE. REVISION SURGERY WAS PERFORMED. PATIENT WAS STABLE ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833132 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 140350 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention