BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZER

    MDR report key: 359322 · Received October 29, 2001

    Report

    Report Number
    359322
    Event Type
    Injury
    Date Received
    October 29, 2001
    Date of Event
    October 23, 2001
    Report Date
    October 24, 2001
    Manufacturer
    SULZER MEDICA, SULZER ORTHOPEDICS, INC
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RIGHT HIP ARTHOPLASTY WITH SULZER CUP. CUP INVOLVED IN RECALL. CUP REINSERTED AFTER EVIDENCE OF LOOSENING; NO EVIDENCE OF INFECTION. NEW SULZER CUP IN PLACE TO REVISE ACETABULAR COMPONENT. WELL FOR BRIEF PERIOD POSTOPERATIVELY FOR SEVERAL MONTHS. BEGAN TO HAVE INCREASING PAIN IN RIGHT GROIN REMINISCENCE PF PRIOR EXPERIENCE. PAIN PROGRESSIVELY WORSENED. BONE SCAN REVEALED INCREASED UPTAKE AROUND ACETABULUM. WORK UP FOR INFECTION NEGATIVE. RADIOGRAPHS REVEALED RADIAL LUCENT LINE ON SMITH PETERSON LATERAL VIEW. CLASSIC FINDING OF LOOSENING ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48418 SULZER SULZER HIP PROSTHESIS COMPONENT LPH SULZER MEDICA, SULZER ORTHOPEDICS, INC * 1463050-CA
    48419 SULZER SULZER HIP PROSTHESIS COMPONENT LPH SULZER MEDICA, SULZER ORTHOPEDICS, INC * 1422244

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R