BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ORTHOPAEDICS

    MDR report key: 4321086 · Received November 13, 2014

    Report

    Report Number
    4321086
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    November 11, 2011
    Report Date
    November 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2011, THIS (B)(6) MALE UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY UNDER DR(B)(6) AT (B)(6) HOSP. A STRYKER REJUVENATE MODULAR NECK AND STEM DEVICE WAS IMPLANTED. PT BECAME SYMPTOMATIC WITH HIS HIP AND WENT TO SEE (B)(6)ON (B)(6) 2014. (B)(6) 2014, PT UNDERWENT REVISION OF LEFT HIP AND HAD STRYKER REJUVENATE DEVICE EXPLANTED BY DR (B)(6). EXTENSIVE DEBRIDEMENT OF THE JOINT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733871 STRYKER ORTHOPAEDICS HIP IMPLANT KWL STRYKER ORTHOPAEDICS MKM0EE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization