BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM R

    MDR report key: 10118171 · Received June 4, 2020

    Report

    Report Number
    3005180920-2020-00310
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 4, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862717
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MAY 2020: LOT 141429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE TIBIAL TRAY AND POLY 2 YEARS AND 8 MONTHS AFTER PRIMARY. NEW LINER HAS THE SAME HEIGHT OF THE OLD ONE, BUT 5MM AUMENTS WERE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583545 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0613FR 141429 07630030862717

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention