BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORMET RESURFACING

    MDR report key: 2992702 · Received March 1, 2013

    Report

    Report Number
    9614209-2013-00003
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    October 20, 2008
    Report Date
    February 14, 2013
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    CORMET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89413 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN MEDICAL, LTD. 179.250B KGYD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization ASSOCIATED CORMET HEAD: 179.044B, LOT KTRG