BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET METAL ON METAL HIP RESURFACING

    MDR report key: 1734102 · Received June 23, 2010

    Report

    Report Number
    9614209-2010-00006
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    March 3, 2010
    Report Date
    May 13, 2010
    Manufacturer
    CORIN LTD
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STATEMENT THAT POSTERATIVELY THERE WAS EVIDENCE OF METALLOSIS, (NO PATHOLOGY REPORT).

    Description of Event or Problem · 1

    PATIENT WAS REVISED 3 YEARS AFTER IMPLANTATION DUE TO ACETABULAR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMET METAL ON METAL HIP RESURFACING CORMET ACETABULAR CUP COMPONENT NXT CORIN LTD IMWV

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R CATALOG# 179.048| CORMET FEMORAL HEAD COMPONENT| EXPIRATION DATE: 09/31/2010| LOT NO. JGEG