BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L

    MDR report key: 8288677 · Received January 30, 2019

    Report

    Report Number
    3005180920-2019-00012
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    December 31, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862649
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JANUARY 2019: LOT 171867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2017. EXPIRATION DATE: 2022-05-11. 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 DUE TO A FALL 8 MONTHS AFTER PRIMARY. THE SURGEON REVIEWED THE PATIENT AND DETERMINED THAT INSTABILITY WAS THE CAUSE OF THE FALL. A REVISION WAS PERFORMED AND THE 02.12.0511FL SIZE 11MM S5 WAS REMOVED AND REPLACED WITH A 02.12.0517FL 17MM S5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81848 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 171867 07630030862649

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention