BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED SIZE 3 NARROW / RIGHT

    MDR report key: 8455409 · Received March 27, 2019

    Report

    Report Number
    3005180920-2019-00193
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820342
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANTIBIOTIC SPACER HAS BEEN REMOVED ON MAY 31 AND A PERMANENT HARDWARE HAS BEEN IMPLANTED.

    Description of Event or Problem · 0

    ON THE (B)(6) 2019, 3 MOTHS AFTER THE REVISION SURGERY THE SURGEON REMOVED THE SPACER AND IMPLANTED THE DEFINITIVE IMPLANTS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MARCH 2019: LOT 130872: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MARCH-2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES WERE INVOLVED IN THE COMPLAINT: GMK-PRIMARY 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R LOT. 130006 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2013 . EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.0214FUC TIBIAL INSERT UC FIXED SIZE 2 / 14 MM LOT. 123064 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2012. EXPIRATION DATE: 2017-09-30. 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-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT. 130248 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY AFTER 5 YEARS AND 9 MONTHS FROM THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249592 GMK-PRIMARY FEMUR CEMENTED SIZE 3 NARROW / RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 07630030820342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention