BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 2 R

    MDR report key: 12851834 · Received November 22, 2021

    Report

    Report Number
    3005180920-2021-00901
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820182
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 OCTOBER 2021. LOT 112969: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2011. EXPIRATION DATE: 2016-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017. ADDITIONAL COMPONENTS INVOLVED: GMK-PRIMARY 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT. 112934 LOT 112934: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEP-2011. EXPIRATION DATE: 2016-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017. GMK-PRIMARY 02.07.0212FUC TIBIAL INSERT UC FIXED SIZE 2 / 12 MM (K090988) LOT. 103786. LOT 103786: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2011. EXPIRATION DATE: 2015-DEC-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 0

    AT 9 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751969 GMK-PRIMARY FEMUR STD CEMENTED SIZE 2 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2002R 112969 07630030820182

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention