BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER TIBIAL COMPONENT

    MDR report key: 2911057 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90029
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT IS ENROLLED IN THE (B)(4) CLINICAL STUDY. THE SUBJECT UNDERWENT A REVISION OF THEIR PRIMARY STRYKER KNEE SYSTEM ON (B)(6) 2012 DUE TO ASEPTIC FAILURE OF THE KNEE AND FAILED FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4336 UNKNOWN STRYKER TIBIAL COMPONENT IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention