BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R

    MDR report key: 9961387 · Received April 15, 2020

    Report

    Report Number
    3005180920-2020-00238
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 16, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    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 26 MARCH 2020: LOT 173819: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    ABOUT TWO YEARS AFTER PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY IN THE KNEE. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 12MM SIZE 5 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 17MM SIZE 5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425498 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0512FR 173819 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention