BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L

    MDR report key: 17001451 · Received May 25, 2023

    Report

    Report Number
    3005180920-2023-00376
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862601
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04-MAY-2023. LOT 2112458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2021. EXPIRATION DATE: 2026-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 95 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651241 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0411FL 2112458 07630030862601

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention