BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT FIXED PS SIZE 6/12MM

    MDR report key: 6847609 · Received September 7, 2017

    Report

    Report Number
    3005180920-2017-00497
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 8, 2017
    Report Date
    September 7, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818905
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 121925: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 SEPTEMBER 2012. EXPIRATION DATE: 2017-08-31. 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 CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627554 GMK-PRIMARY TIBIAL INSERT FIXED PS SIZE 6/12MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 121925 07630030818905

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention