BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

    MDR report key: 11154510 · Received January 12, 2021

    Report

    Report Number
    3005180920-2021-00044
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    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 22 DECEMBER 2020: LOT 2000428: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2020. EXPIRATION DATE: 2025-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    LINER REVISION AND WASHOUT PERFORMED 1 MONTH AFTER THE PRIMARY SURGERY DUE TO AN INFECTION (STAPHYLOCOCCUS). THE INSERT WAS EXCHANGED FOR ONE OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53927 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0210FR 2000428 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention