BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 2 L

    MDR report key: 8473645 · Received April 2, 2019

    Report

    Report Number
    3005180920-2019-00240
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821387
    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 01 APRIL 2019: LOT 160307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2016. EXPIRATION DATE: 2021-03-03. 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. ADDITIONAL COMPONENTS INVOLVED: GMK-REVISION 02.07.0681L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 L (K123721), LOT 155877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2016. EXPIRATION DATE: 2020-12-19. 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. GMK-REVISION 02.07.0110SCF FIXED TIBIAL INSERT SC SIZE 1/10MM (K103170), LOT 155555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2015. EXPIRATION DATE: 2020-08-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION. THE SURGEON EXPLANTED ALL IMPLANTS, PERFORMED A WASHOUT AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266929 GMK-REVISION FEMUR REVISION PS SIZE 2 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 160307 07630030821387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention