BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM, SIZE 3

    MDR report key: 479917 · Received August 20, 2003

    Report

    Report Number
    479917
    Event Type
    Injury
    Date Received
    August 20, 2003
    Date of Event
    August 12, 2003
    Report Date
    August 20, 2003
    Manufacturer
    SULZER ORTHOPEDICS, INC
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/27/03: IN RESPONSE TO LETTER DATED SEPT 8, 2003, AND AS DISCUSSED IN 10/2003, CO HAS REVIEWED DATA FROM ITS COMPLAINT HANDLING SYSTEM AND IDENTIFIED THAT THIS USER FACILITY MEDWATCH WAS REVIEWED, ADDRESSED AND ASSIGNED ITS INVESTIGATION NUMBER P03-0659 ON 09/2003. THE CATALOG NUMBER (4360-00-053, LOT NUMBER 1366392) OF THE PRIMARY DEVICE INVOLVED IS FOR AN INTER-OP HEMISPHERICAL POROUS SHELL WITH SEALED SCREWHOLES SIZE 53MM. SURGICAL REMOVAL OF THE DEVICE WAS BASED ON IT BEING A RECALLED SULZER ORTHOPEDICS, INC (CENTERPULSE ORTHOPEDICS, INC) SHELL. REPORTING OF THESE DEVICES WAS HALTED ONCE CENTERPULSE ORTHOPEDICS, INC RECEIVED REMEDIAL ACTION EXEMPTION #E2001017 FROM MONITORING BRANCH DIVISION OF SURVEILLANCE SYSTEMS OFFICE OF SURVEILLANCE AND BIOMETRICS, CENTER FOR DEVICES AND RADIOGRAPHIC HEALTH. AS A RESULT CENTERPULSE ORTHOPEDICS, INC WILL NOT BE REPORTING/FORWARDING A MANDATORY MEDWATCH FOR THIS EVENT.

    Description of Event or Problem · 1

    PT HAD TOTAL HIP ARTHROPLASTY FOR POST-TRAUMATIC OSTEONECROSIS OF FEMORAL HEAD IN 1999. IN 2003 A RESECTION OF THE RIGHT HIP ARTHROPLASTY WAS DONE WITH IMPLANTATION OF ANTIBIOTIC BEADS DUE TO AN INFECTION. REMOVAL ALSO INDICATED DUE TO REPORT OF RECALL BY MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL STEM, SIZE 3 COMPONENTS FROM TOTAL HIP ARTHROPLASTY KWY SULZER ORTHOPEDICS, INC * *
    2 SHELL, 53MM COMPONENTS FROM TOTAL HIP ARTHROPLASTY KWB SULZER ORTHOPEDICS, INC * *
    3 SCREWS COMPONENTS FROM TOTAL HIP ARTHROPLASTY HWC SILZER ORTHOPEDICS, INC * *
    4 LINER COMPONENTS FROM TOTAL HIP ARTHROPLASTY KWB SULZER ORTHOPEDICS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R HOLE COVER ELIMINATOR.