BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURE-FIT HA ACETABULAR SHELL

    MDR report key: 282085 · Received June 13, 2000

    Report

    Report Number
    2243265-2000-00041
    Event Type
    Injury
    Date Received
    June 13, 2000
    Date of Event
    May 12, 2000
    Report Date
    June 13, 2000
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    MEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BY X-RAY (ENCLOSED) INSERT APPEARED TO HAVE DISENGAGED FROM SHELL, DOCTOR SHCEDULED REVISION FOR FOLLOWING DAY TO REPLACE LINER. INTER-OP FOUND EXCESSIVE WEAR ON SHELL & LINER. REMOVED HEAD, SHELL AND LINER, AND REPLACED WITH 2051-2059, 2042-3250, 16-3200 AND 2030-6520.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE-FIT HA ACETABULAR SHELL IMPLANT MEH HOWMEDICA OSTEONICS NA 32122801

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention