BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 6 R

    MDR report key: 12645636 · Received October 18, 2021

    Report

    Report Number
    3005180920-2021-00817
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820267
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29.SEPTEMBER.2021. LOT 111255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-JUL-2011. EXPIRATION DATE: 2016-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS SINCE 2017. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 100869. BATCH REVIEW PERFORMED ON 29.SEPTEMBER.2021. LOT 100869: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUN-2010. EXPIRATION DATE: 2015-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS SINCE 2017. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0514FUC TIBIAL INSERT UC FIXED SIZE 5 / 14 MM (K090988) LOT. 102842. BATCH REVIEW PERFORMED ON 29.SEPTEMBER.2021. LOT 102842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2010. EXPIRATION DATE: 2015-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: LATE INFECTION IN CEMENTED TKA, 10 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED 9 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. ALL IMPLANTS WERE REVISED. THE PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543150 GMK-PRIMARY FEMUR STD CEMENTED SIZE 6 R CEMENTED FEMUR IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.2006R 111255 07630030820267

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention