BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT

    MDR report key: 6646024 · Received June 16, 2017

    Report

    Report Number
    3005180920-2017-00318
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    February 1, 2017
    Report Date
    June 16, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 31 MAY 2017 AND INCLUDES: THE REVISION SURGERY WAS PERFORMED AS PLANNED ON (B)(6) 2017 AND THE TIBIAL LOOSENING WAS CONFIRMED. TIBIAL TRAY AND LINER ONLY WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 09 JUNE 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL KNEE REVISION SURGERY IN A (B)(6) YEAR-OLD WOMAN 9 MONTHS AFTER PRIMARY CEMENTED TKA. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN THE MEDIAL PART OF THE TIBIAL PLATEAU. COMPONENT LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT FOLLOWING TKA. REASONS OF THIS EVENT IS OFTEN UNKNOWN. IN THIS CASE, THE PATIENT REPORTED HIGH ACTIVITY IN THE LAST PERIOD THAT MAY HAVE CONTRIBUTED TO THE FAILURE BUT THE REAL CAUSE CAN'T BE DETERMINED. BATCH REVIEW PERFORMED ON 12 JUNE 2017. LOT 161488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2016. EXPIRATION DATE: 2021-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET RECEIVED.

    Description of Event or Problem · 1

    KNEE PAIN APPEARED 6 MONTH AFTER SURGERY. MAY BE THE PATIENT WALKED TOO MUCH. IT SEEMS THE TIBIAL PLATEAU IS LOOSENED. THE REVISION SURGERY WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427188 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 161488

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention