BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY PATELLA RESURFACING SIZE 4

    MDR report key: 14191709 · Received April 25, 2022

    Report

    Report Number
    3005180920-2022-00304
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 APRIL 2022. LOT 163388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2016. EXPIRATION DATE: 2021-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. THE SURGEON REVISED THE PATELLA 5 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200137 GMK-PRIMARY PATELLA RESURFACING SIZE 4 KNEE PATELLA JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 163388 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention