BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R

    MDR report key: 15240605 · Received August 17, 2022

    Report

    Report Number
    3005180920-2022-00613
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 19, 2022
    Report Date
    August 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261501
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JULY 2022. LOT 2112612: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2021. EXPIRATION DATE: 2026-11-17. 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 5 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A QUAD TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND UPSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238139 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R KNEE INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.E0310CRR 2112612 07630971261501

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention