BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUMATCH M-SERIES LPB NECK SEGMENT, LOW OFFSET

    MDR report key: 3733299 · Received March 24, 2014

    Report

    Report Number
    1038671-2014-00084
    Event Type
    Other
    Date Received
    March 24, 2014
    Date of Event
    June 1, 2013
    Report Date
    March 21, 2014
    Manufacturer
    EXACTECH INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 EVAL.

    Description of Event or Problem · 1

    REVISION OF ACUMATCH HIP COMPONENTS FOR AN UNK CAUSE. THIS EVENT WAS REPORTED THROUGH EXACTECH'S LEGAL DEPT. PRIMARY SURGERY WAS ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172251 ACUMATCH M-SERIES LPB NECK SEGMENT, LOW OFFSET M-SERIES LPB NECK SEGMENT, LOW OFFSET LZO EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention