BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0310CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM L

    MDR report key: 15869268 · Received November 28, 2022

    Report

    Report Number
    3005180920-2022-00875
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    November 1, 2022
    Report Date
    November 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707336
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-NOV-2022: LOT 2112390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-10-14. 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 THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741943 GMK-SPHERE 02.12.0310CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0310CRL 2112390 07630040707336

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention