BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L

    MDR report key: 11053919 · Received December 22, 2020

    Report

    Report Number
    3005180920-2020-00949
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    November 21, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820212
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 DECEMBER 2020: LOT 123872: (B)(4) TEMS MANUFACTURED AND RELEASED ON 07-NOV-2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 113796. BATCH REVIEW PERFORMED ON 07 DECEMBER 2020: LOT 113796: (B)(4) TEMS MANUFACTURED AND RELEASED ON 23-NOV-2011. EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) TEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0512FUC TIBIAL INSERT UC FIXED SIZE 5 / 12 MM (K090988) LOT. 114251. BATCH REVIEW PERFORMED ON 07 DECEMBER 2020: LOT 114251: (B)(4) TEMS MANUFACTURED AND RELEASED ON 10-FEB-2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) TEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 122440. BATCH REVIEW PERFORMED ON 07 DECEMBER 2020: LOT 122440: (B)(4) TEMS MANUFACTURED AND RELEASED ON 16-OCT-2012. EXPIRATION DATE: 2017-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) TEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 7 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522368 GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L CEMENTED KNEE FEMURAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2004L 123872 07630030820212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention