BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3792178 · Received May 6, 2014

    Report

    Report Number
    0002249697-2014-01735
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    October 25, 2007
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN 33 X 9 PRESS FIT PATELLA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP WAS MADE AWARE ON (B)(6) 2014 THAT THE PATIENT'S 33 X 9 PRESSFIT PATELLA CRACKED OR DISASSOCIATED. THE PATIENT WAS SCHEDULED FOR REVISION SURGERY THE WEEK OF (B)(6) BUT IT HAS BEEN POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270409 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention