BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET METAL ON METAL HIP RESURFACING

    MDR report key: 1961097 · Received January 12, 2011

    Report

    Report Number
    9614209-2010-00023
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    September 14, 2010
    Report Date
    November 26, 2010
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THERE IS EVIDENCE OF LOOSENING OF THE COATING. IT IS NOT POSSIBLE TO DETERMINE WHETHER THIS WAS THE PRIMARY CAUSE OF, OR SECONDARY TO, THE CUP LOOSENING. (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY, 6 YRS AFTER IMPLANTATION, DUE TO FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMET METAL ON METAL HIP RESURFACING NXT PROST HIP SEMI-CONST MET/MET RESURF NXT CORIN LTD. HYNZ

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R CATALOG# 179.052, LOT# HYHP| CORMET FEMORAL HEAD COMPONENT: