BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    MDR report key: 10300529 · Received July 21, 2020

    Report

    Report Number
    3005180920-2020-00452
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2020: LOT 180406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-04-11. 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 REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE MEDACTA GMK-SPHERE TIBIAL INSERT - FLEX S4R - 10 MM WITH A MEDACTA SPHERE INSERT FLEX RIGHT 13MM S4 1 YEAR AND 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768049 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 180406 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention