BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 2 RIGHT

    MDR report key: 6851057 · Received September 8, 2017

    Report

    Report Number
    3005180920-2017-00502
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 11, 2017
    Report Date
    September 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825422
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 162147: 17 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE EXTENSION STEM - FLUTED Ø 16 L 65, CODE 02.07.FCL16065, LOT. 162547 (K120790) 40 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE FIXED TIBIAL INSERT SIZE 2/12MM, CODE 02.09.0212H, LOT. 150741 (K130299) 20 INSERTS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: (B)(6) 2020. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LIMITED RANGE OF MOTION. THE PATIENT HAD 40 DEGREES CONTRACTURE FOLLOWING THE PRIMARY TKA WITH A GMK-HINGE. PREOPERATIVE, THE PATIENT WAS 25 DEGREES CONTRACTURE. THE SURGEON PERFORMED A FEMORAL SHORTENING, WHICH ALLOWED PATIENT TO HAVE FULL RANGE OF MOTION, AND REVISED THE FEMUR, POLY AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632418 GMK-HINGE FEMORAL COMPONENT SIZE 2 RIGHT KNEE FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 162147 07630030825422

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention