BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMI POR SHL W/SEALED SCWHLS SZ59MM I-O

    MDR report key: 331575 · Received April 20, 2001

    Report

    Report Number
    2935620-2001-00739
    Event Type
    Injury
    Date Received
    April 20, 2001
    Date of Event
    December 6, 2000
    Report Date
    March 21, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: THE PT HAD OSTEOARTHRITIS OF BOTH HIPS. IN 1999 THE PT UNDERWENT AN INTER-MEDICS LEFT TOTAL HIP REPLACEMENT. IN 2000, AN INTERMEDICS RIGHT TOTAL HIP REPLACEMENT WAS PERFORMED. SULZER MEDICA INTER-OP ACETABUALR COMPONENTS WERE USED FOR BOTH HIPS. THE PT HAD SEVERE PAIN POST-OP AND 11 MONTHS LATER PT REQUIRED A RE-OP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18353 HEMI POR SHL W/SEALED SCWHLS SZ59MM I-O HIP PROSTHESIS LPH SULZER ORTHOPEDICS, INC. NA 1409389

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R