BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM

    MDR report key: 8137077 · Received December 6, 2018

    Report

    Report Number
    3005180920-2018-00973
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818295
    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 04 DECEMBER 2018: LOT 102841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2010 . EXPIRATION DATE: 2015-09-30. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 7 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON RESURFACED THE ORIGINAL PATELLA WITH ANOTHER COMPANY'S PRODUCT AND PERFORMED A POLY SWAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976649 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 102841 07630030818295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention