BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE STP

    MDR report key: 3516593 · Received December 5, 2013

    Report

    Report Number
    3516593
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 5, 2013
    Manufacturer
    STRYKER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR HIP REVISION D/T PAIN AT LEFT HIP IMPLANT. PT HAD STYKER REJUVENATE IMPLANT IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631421 REJUVENATE STP IMPLANT, HIP LPH STRYKER, INC. SPT-070000S *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR