BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/10 MM R

    MDR report key: 15987325 · Received December 15, 2022

    Report

    Report Number
    3005180920-2022-00937
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262225
    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 07 DECEMBER 2022: LOT 2112642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570166 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0610CRR 2112642 07630971262225

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention