BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER REJUVENATE MODULAR NECK

    MDR report key: 3092191 · Received April 26, 2013

    Report

    Report Number
    MW5030009
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT HAD A STRYKER REJUVENATE HIP DEVICE PLACED IN HER LEFT HIP. ON (B)(6) 2012, STRYKER ISSUED A VOLUNTARY RECALL FOR THE REJUVENATE MODULAR STEM AND NECK. ON (B)(6)2013, PT BECAME SYMPTOMATIC AND HAD STRYKER REJUVENATE HIP DEVICE EXPLANTED AND UNDERWENT REVISION OF TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181861 STRYKER REJUVENATE MODULAR NECK HIP REPLACEMENT DEVICE MEH STRYKER ORTHOPAEDICS NLS-340000B 35752601
    181863 STRYKER REJUVENATE MODULAR STEM HIP REPLACEMENT DEVICE MEH STRYKER ORTHOPAEDICS MKAELR

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R| S