BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER REJUVENATE

    MDR report key: 2892715 · Received December 21, 2012

    Report

    Report Number
    MW5028354
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REQUIRED READMISSION AND EXPLANTATION OF PREVIOUSLY PLACED TOTAL HIP PROSTHESIS. HAD DEVELOPED ENLARGING CYST. DATE OF USE: (B)(6)2011 - (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: DJD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER REJUVENATE TOTAL HIP PROSTHESIS JDI STRYKER ORTHOPAEDICS NLS-34000B
    2 HEAD FEMORAL JDI 8 LOG48286
    3 NECK HIP MODULAR JDI 33MM LOG48286

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R