BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

    MDR report key: 18272869 · Received December 6, 2023

    Report

    Report Number
    3005180920-2023-00946
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 6, 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 15 NOVEMBER 2023, LOT 2243291: 120 ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2023. EXPIRATION DATE: 2028-01-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 105 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    2161417 GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 2243291 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention