BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 1 L

    MDR report key: 9693709 · Received February 11, 2020

    Report

    Report Number
    3005180920-2020-00044
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821363
    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 22 JANUARY 2020: LOT 167069: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DIC-2016. EXPIRATION DATE: 2021-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT OTHER DEVICE INVOLVED BATCH REVIEW PERFORMED ON 22 JANUARY 2020: GMK-REVISION 02.07.0212SCF FIXED TIBIAL INSERT SC SIZE 2/12MM (K103170) LOT 189525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-MAR-2019. EXPIRATION DATE: 2024-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED.

    Description of Event or Problem · 1

    REVISION SURGERY AFTER 7 DAYS FROM THE PRIMARY DUE TO DISLOCATION (FEMORAL COMPONENT FROM THE LINER). THE PATIENT HAD A BONE LOSS OF THE LATERAL FEMORAL CONDYLE AND LATERAL LIGAMENT WAS COMPROMISED AFTER PREVIOUS REVISION SURGERY (REMOVAL OF ALL IMPLANTS DUE TO AN INFECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158006 GMK-REVISION FEMUR REVISION PS SIZE 1 L KNEE FEMUR IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.2401L 167069 07630030821363

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention