BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM

    MDR report key: 8631620 · Received May 22, 2019

    Report

    Report Number
    3005180920-2019-00396
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 MAY 2019: LOT 162283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2016. EXPIRATION DATE: 2021-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 YEAR AND 9 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT KNEE. THE PATIENT WAS COMPLAINING PAIN IN THE ANTERIOR KNEE. THE REASON OF PAIN IS UNKNOWN. THE SURGEON RESURFACED THE PATELLA AND REVISED THE 10MM POLY WITH A 12MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427693 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM KNEE POLYETHYLENE INSERT JWH MEDACTA INTERNATIONAL SA 162283 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention