BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4/10 MM

    MDR report key: 10013153 · Received April 30, 2020

    Report

    Report Number
    3005180920-2020-00263
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    March 31, 2020
    Report Date
    April 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817663
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 APRIL 2020: LOT 162471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2016. EXPIRATION DATE: 2021-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND DID NOT REVISE ANY IMPLANTS. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477323 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4/10 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0410SF 162471 07630030817663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention