BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS

    MDR report key: 17134332 · Received June 15, 2023

    Report

    Report Number
    3005180920-2023-00444
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261761
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORED ON 30-MAY-2023: LOT 2241318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE E-CROSS LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230834 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0410FR 2241318 07630971261761

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention