BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 5 L

    MDR report key: 8987629 · Received September 11, 2019

    Report

    Report Number
    3005180920-2019-00754
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821448
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 AUGUST 2019: LOT 173070: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2017. EXPIRATION DATE: 2022-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW MONTHS AFTER REVISION TKA THE FEMORAL COMPONENT GOT LOOSE AND NEEDED REVISION. THE INFORMATION SUPPLIED IS NOT ENOUGH TO DETECT ANY SPECIFIC CAUSE FOR THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED THE FEMORAL COMPONENT, STEM, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785486 GMK-REVISION FEMUR REVISION PS SIZE 5 L CEMENTED KNEE FEMUR JWH MEDACTA INTERNATIONAL SA 173070 07630030821448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention