BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM

    MDR report key: 7362185 · Received March 22, 2018

    Report

    Report Number
    3005180920-2018-00173
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817168
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 08 MAY 2018: THE PATIENT WAS REVISED ON(B)(6) 2018. THE SURGEON SWAPPED THE POLY WITH A THICKER ONE (REF 02.07.0317PSF). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 MARCH 2018; LOT 133286: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 SEPTEMBER 2013. EXPIRATION DATE: 2018-08-31. 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 SURGEON NOTIFIED SALES REPRESENTATIVE ON (B)(6) 2018 THAT THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE PATIENT WAS LOOSE IN FLEXION AND EXTENSION. THE SURGEON PLANS TO REVISE THE POLY ON (B)(6) 2018. ON (B)(6) 2018 WE WERE INFORMED THAT THIS CASE IS CANCELLED UNTIL FURTHER NOTICE. THE PATIENT HAS BEEN SMOKING AND THUS CANNOT PERFORM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204538 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM TIBIAL INSERT PS FIXED JWH MEDACTA INTERNATIONAL SA 133286 07630030817168

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention