BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    MDR report key: 9738052 · Received February 21, 2020

    Report

    Report Number
    3005180920-2020-00079
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    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 03.02.2020: LOT 1900377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 2024-APR-10. 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

    REVISION SURGERY PERFORMED 22 DAYS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND INSERT-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201550 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0414FL 1900377 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention