BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    MDR report key: 15376910 · Received September 8, 2022

    Report

    Report Number
    3005180920-2022-00674
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 AUGUST 2022. LOT 2001733: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2020. EXPIRATION DATE: 2025-MAR-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION PERFORMED 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. ONLY INSERT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319547 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0412FR 2001733 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention