BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 6 R

    MDR report key: 11692160 · Received April 20, 2021

    Report

    Report Number
    3005180920-2021-00318
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 20, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821479
    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 31.MAR.2021: LOT 1810572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21.03.2019. EXPIRATION DATE: 2024-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.0517SCF FIXED TIBIAL INSERT SC SIZE 5/17MM (K103170) LOT. 188129. BATCH REVIEW PERFORMED ON 31.MAR.2021: LOT 188129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21.11.2018. EXPIRATION DATE: 2023-11-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. THE SURGEON OBSERVED THAT THE PATIENT HAD SOFT TISSUE DAMAGE AND A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT AND ADDED OFFSET CONNECTORS, FEMORAL WEDGES, FLUTED EXTENSION STEMS AND TIBIAL AUGMENTS. PREVIOUSLY THE PATIENT HAD COMPETITOR IMPLANTS AND WAS REVISED ON (B)(6) 2020 FOLLOWING AN INFECTION, MEDACTA IMPLANTS WERE USED AS AN ANTIBIOTIC SPACER. ON (B)(6) 2020 THE PERMANENT MEDACTA HARDWARE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591052 GMK-REVISION FEMUR REVISION PS SIZE 6 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2406R 1810572 07630030821479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention