BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/12 MM R E-CROSS LOT.

    MDR report key: 17296867 · Received July 11, 2023

    Report

    Report Number
    3005180920-2023-00510
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 11, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261129
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 JUNE 2023. LOT 2002502: 30 ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2020. EXPIRATION DATE: 2025-NOV-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 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 HAD A PRIMARY KNEE ON (B)(6) 2023. ON (B)(6) 2023, 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. PRESENTLY, ON (B)(6) 2023, 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
    1586682 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/12 MM R E-CROSS LOT. TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.E0112FR 2002502 07630971261129

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention