BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 8498767 · Received April 10, 2019

    Report

    Report Number
    3005180920-2019-00254
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED ON 01.MAY.2019 BY MEDACTA USA: THE REVISION SURGERY WAS FINALLY PERFORMED ON (B)(6) 2019. THE SURGEON REVISED THE POLY AND TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION PROVIDED ON 02.MAY.2019 BY MEDACTA USA: THE INLAY THAT WAS REMOVED WAS AN INSERT PS 10 MM. ADDITIONAL INFORMATION PROVIDED ON 28.MAY.2019 BY MEDACTA USA: THE SURGEON IMPLANTED A 12 MM LINER DURING THE REVISION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 APRIL 2019: LOT 154002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2015. EXPIRATION DATE: 2020-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT ((B)(4)]). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: 3 YEARS AFTER TOTAL KNEE IMPLANTATION, THE PATIENT WAS COMPLAINING ABOUT PAIN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH IS AVAILABLE. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF A SUBSIDED TIBIAL COMPONENT. INITIAL POSITION OF THIS COMPONENT CANNOT BE ASSESSED NOT HAVING AN IMMEDIATE POSTOPERATIVE X-RAY, THEREFORE WE CANNOT EVALUATE THE LEVEL OF CORTICAL BONE COVERAGE POSTOPERATIVELY. THE REASON OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE TIBIAL TRAY (LEFT). NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME. MORE DETAILS TO FOLLOW ONCE THE CASE HAS BEEN SCHEDULED AND COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294972 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L KNEE FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 154002 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Other