BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS

    MDR report key: 2021736 · Received March 11, 2011

    Report

    Report Number
    MW5019806
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    May 26, 2004
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED HIP REPLACEMENT ON THIS DATE. BEST I CAN DETERMINE THE MANUFACTURER IS VERSYS. HAD CONTINUAL PAIN AND HAVE BEEN BACK TO THE DOCTOR WHO INSTALLED THE REPLACEMENT AND HE CONTINUALLY TOLD ME THAT EVERYTHING LOOKED OKAY. HAD TESTS DONE BY THE (B)(6) AND THEIR REPORT SAYS "THE FLOW STUDY SHOWS SYMMETRICAL PERFUSION TO THE PELVIS. BLOOD POOL IMAGING SHOWS A PHOTEPENIC DEFECT CORRESPONDING TO THE RIGHT HIP PROSTHESIS. THREE HOUR DELAYED IMAGING SHOWS MILD DIFFUSELY INCREASED UPTAKE THROUGHOUT THE RIGHT ACETABULUM WITH MORE FOCAL INTENSE TRACER UPTAKE IN THE SUPERIOR LATERAL ASPECT, AND MILDLY INCREASED UPTAKE IN THE LATERAL ASPECT OF THE MID FEMUR AT THE LEVEL OF THE TIP OF THE PROSTHESIS." "IMPRESSION: THE FINDINGS OF THE THREE PHASE BONE SCAN SUGGEST POSSIBLE LOOSENING OF THE RIGHT HIP PROSTHESIS AT THE ACETABULAR COMPONENT, ESPECIALLY SUPERIOR LATERAL ASPECT, AND LATERAL MID FEMUR AT THE TIP OF THE PROSTHESIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS VERSYS STEM LPH ZIMMER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention