BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

    MDR report key: 17123886 · Received June 14, 2023

    Report

    Report Number
    3005180920-2023-00438
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 MAY 2023: LOT 2243291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2023. EXPIRATION DATE: 2028-JAN-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082585 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L KNEE TIBIAL INSERT POLYETHYLENE JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 2243291 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention