BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH M-SERIES METAPHYSEAL

    MDR report key: 3853547 · Received June 3, 2014

    Report

    Report Number
    1038671-2014-00181
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 28, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    A TOTAL HIP ARTHROPLASTY WAS REVISED APPROXIMATELY 14 YEARS POST-OPERATIVELY BECAUSE OF A FRACTURE IN THE MODULAR STEM PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323233 ACUMATCH M-SERIES METAPHYSEAL M-SERIES METAPHYSEAL LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R