BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE HIP IMPLANT

    MDR report key: 8546252 · Received April 23, 2019

    Report

    Report Number
    MW5086117
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    February 2, 2009
    Report Date
    April 21, 2019
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MOM HIP REPLACEMENT WITH DEPUY PINNACLE IN 2009. SIDE EFFECTS OVER THE YEARS INCLUDE TINNITUS, POSSIBLE RETINAL DETACHMENT, SEVERE DEPRESSION, ANXIETY, EXTREME WEIGHT GAIN, INABILITY TO WALK, CIRCULATORY PROBLEMS METALLOSIS. HIP REVISION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331681 DEPUY PINNACLE HIP IMPLANT PROSTHESIS, HIP LPH DEPUY SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| O| R| S