BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 5 R

    MDR report key: 7788798 · Received August 16, 2018

    Report

    Report Number
    3005180920-2018-00605
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825484
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 AUGUST 2018. LOT 168960: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 APRIL 2017. EXPIRATION DATE: 2022-03-23 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) PIECES OF THE SAME LOT HAS BEEN SOLD AND NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. GMK-HINGE FIXED TIBIAL TRAY SIZE 5 R REFERENCE 02.09.4005R (K130299). LOT 167694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JANUARY 2017. EXPIRATION DATE: 2022-01-10 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-HINGE FIXED TIBIAL INSERT # 5/12 MM REFERENCE 02.09.0512H (K130299). LOT 173990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-27 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-HINGE EXTENSION STEM - FLUTED Ø 22 L 105 REFERENCE 02.07.FCL22105 (K120790). LOT 161797: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2016. EXPIRATION DATE: 2021-04-25. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 7 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. THE DATE IN WHICH THE SPACER WAS IMPLANTED IS UNKNOWN. THE SURGEON IMPLANTED PERMANENT HARDWARE ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632342 GMK-HINGE FEMORAL COMPONENT SIZE 5 R FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 168960 07630030825484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention