BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMALOC

    MDR report key: 1744665 · Received June 30, 2010

    Report

    Report Number
    1722511-2010-00004
    Event Type
    Other
    Date Received
    June 30, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STEM WAS ORTHOMAX (A PREDECESSOR TO ORTHO DEVELOPMENT CORPORATION; (B)(4)) AND WAS ORIGINALLY IMPLANTED IN 1994. THE HEAD THAT WAS REQUESTED BY THE SURGEON AND PROVIDED WAS PRIMALOC (B)(4). THIS HEAD DID NOT FIT THE ORIGINAL STEM DUE TO A DIFFERENCE IN THE TAPER. REPLACEMENT COMPONENTS OF THIS STEM (B)(4) WERE OBTAINED AND HAVE BEEN PROVIDED TO THE SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2010, THE PATIENT UNDERWENT ACETABULAR REVISION, AND WAS REVISED WITH A PRIMALOC HEAD AS REQUESTED BY THE SURGEON. IN (B)(6) 2010, THE FEMORAL HEAD DISASSOCIATED FROM THE STEM DUE TO A DIFFERENCE IN THE TAPERS. THE PATIENT WAS REVISED TO A PROVISIONAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMALOC FEMORAL HEAD LZO ORTHO DEVELOPMENT CORP. NA 00003483

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention