BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR PS SIZE 4 L

    MDR report key: 12188683 · Received July 19, 2021

    Report

    Report Number
    3005180920-2021-00600
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821424
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JULY 2021: LOT 164175: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2016. EXPIRATION DATE: 2021-07-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 05 JULY 2021: GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L (K123721) LOT 156848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2016. EXPIRATION DATE: 2021-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0412SCF FIXED TIBIAL INSERT SC SIZE 4/12MM (K103170) LOT 165093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2016. EXPIRATION DATE: 2021-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY WAS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN 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
    1085296 GMK-REVISION FEMUR PS SIZE 4 L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2404L 164175 07630030821424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention