BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 9283646 · Received November 6, 2019

    Report

    Report Number
    3005180920-2019-00937
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 8, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 OCTOBER 2019: LOT 161483: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2016. EXPIRATION DATE: 2021-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL DIRECTOR: 3 YEARS AFTER TKA THE CEMENTED TIBIAL TRAY IS FOUND LOOSE AND EXCHANGED. THE RADIOGRAPHY SUPPLIED SHOWS A CLEARLY LOOSENED PLATE; MOST PROBABLY THE INTERFACE THAT LOST CONNECTION IS BETWEEN CEMENT AND METAL. THE REASONS FOR THIS FAILURE CANNOT BE DETERMINED WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, THREE YEARS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A LOOSE TIBIAL BASE PLATE. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA, STEM, AND POLY AND IMPLANTED A REVISION BASEPLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082798 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 161483 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention