BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT FIXED SIZE 2 / 14 MM

    MDR report key: 8456538 · Received March 27, 2019

    Report

    Report Number
    3005180920-2019-00191
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816659
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MARCH 2019: LOT 134898: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JANUARY 2014. EXPIRATION DATE: 2018-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 3 SIMILAR REPORTED EVENTS (B)(4). OTHER DEVICES WERE INVOLVED IN THE COMPLAINT: GMK-PRIMARY 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L LOT. 154442 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2015. EXPIRATION DATE: 2020-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. GMK-PRIMARY 02.07.2002L FEMUR STD CEMENTED SIZE 2 L LOT. 131810 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: REVISION IN TKA 2 YEARS AND 3 MONTHS AFTER PRIMARY FOR JOINT INSTABILITY. THE SURGEON DECIDED TO REPLACE THE IMPLANT TO INCREASE SOFT TISSUE TENSION AND KNEE STABILITY. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. THIS IS NOT A PROBLEM DUE TO ANY IMPLANT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND THREE MONTHS AFTER PRIMARY, THE SURGEON REVISED THE PATIENT FOR INSTABILITY DUE TO KNEE LAXITY. THE CAUSE OF LAXITY IS UNKNOWN. THE SURGEON SWAPPED ALL THE HARDWARE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250645 GMK-PRIMARY TIBIAL INSERT FIXED SIZE 2 / 14 MM KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 134898 07630030816659

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention