BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON UNIVERSAL B/P NON-BEADED

    MDR report key: 2912766 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90060
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K915512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PATHOLOGIC FX OF MEDIAL TIBIA CAUSING BASEPLATE TO SUBSIDE POSTERIOR MEDIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8226 DURACON UNIVERSAL B/P NON-BEADED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention