BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    MDR report key: 8292560 · Received January 31, 2019

    Report

    Report Number
    3005180920-2019-00020
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    November 1, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JANUARY 2019: LOT 152453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2015. EXPIRATION DATE: 2020-10-19. 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED TWO MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT OF THE INFECTED KNEE AND HE REPLACED THE INSERT WITH AN INSERT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86218 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 152453 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention