BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TIBIAL BASE PLATE

    MDR report key: 7163357 · Received January 4, 2018

    Report

    Report Number
    3005180920-2017-00810
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    December 5, 2017
    Report Date
    January 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819841
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 DEC 2017 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: THE IMAGES SUPPLIED ARE OF EXTREMELY POOR QUALITY AND DO NOT ALLOW PROPER EVALUATION. THE TIBIAL PLATEAU SEEMS TO BE PLACED MEDIAL AND POSTERIOR, WITH A LATERAL WEAKENING OF THE SUPPORTING TIBIAL BONE, BUT THIS IS MORE GUESSING THAT ASSESSING. THE RELATIONSHIP BETWEEN THIS POSITION, WHICH MAY BE DUE TO ANATOMICAL CONSTRAINTS NOT DETECTABLE FROM THE XRAYS SUPPLIED, IS UNKNOWN. BATCH REVIEW PERFORMED ON 02 JANUARY 2018: LOT 091670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 AUGUST 2009. EXPIRATION DATE: 2014-06-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION BASED ON THE PICTURE OF THE EXPLANTED COMPONENT, MADE ON 03 JAN 2018 BY R&D PROJECT MANAGER: NO RESIDUAL CEMENT CAN BE SEEN ON THE BOTTOM SURFACE OF THE TIBIA BASEPLATE. IT IS SOMETHING USUAL TO BE SEEN ON EXPLANTED COMPONENTS, EVEN IF THE CAUSE OF REVISION IS NOT LOOSENING OR MOBILIZATION. SOME RESIDUAL MATERIAL CAN BE SEEN SURROUNDING THE TIBIA KEEL, BUT IT IS NOT CLEAR FROM THE IMAGE IF IT IS CEMENT OR BONE. NO FURTHER COMMENTS OR CONSIDERATIONS CAN BE DONE LOOKING AT THE PICTURE SENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE TIBIAL BASEPLATE HAD SUBSIDED. THE SURGEON REVISED THE TIBIAL BASEPLATE AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9181 GMK TIBIAL BASE PLATE FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 091670 07630030819841

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention