BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 8133925 · Received December 5, 2018

    Report

    Report Number
    3005180920-2018-00967
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    November 7, 2018
    Report Date
    December 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2018: LOT 181943: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JUL 2018. EXPIRATION DATE: 2023-07-01. 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. CLINICAL EVALUATION PERFORMED ON NOVEMBER 21, "20018": INTRAOPERATIVE TIBIAL FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL KNEE REPLACEMENTS. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 1

    DURING THE PRIMARY TOTAL KNEE SURGERY AND PRIOR TO CEMENTING THE TIBIAL TRAY, IT WAS DISCOVERED THAT THE PATIENT HAD A MEDIAL TIBIAL PLATEAU FRACTURE. THE SURGEON PROCEEDED WITH CEMENTING THE TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON PLANS TO FOLLOW UP WITH THE PATIENT IN THE FUTURE TO DETERMINE IF THE FRACTURE HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973987 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 181943 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention