BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT POR TAPER SZ3 HI OFF

    MDR report key: 3141114 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17991
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT WILL UNDERGO REVISION SURGERY TO ADDRESS DISCOMFORT AND PAIN. DOI: (B)(6) 2008 - NOT REVISED YET (LEFT HIP. PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(6) 2012- MEDICAL RECORDS RECEIVED (B)(6) 2012, FOR RIGHT SIDED HIP LEADING TO INVOICE WITH PART AND LOT INFORMATION FOR LEFT HIP. UPDATE: (B)(6) 2012-SALES REP REPORTED REVISION SURGERY DUE TO METALLOSIS. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOR: (B)(6) 2012. THIS IS A CLINICAL PATIENT: SUBJECT # (B)(6); NO NEW INFORMATION WAS PROVIDED THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2013- PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS INCREASED METAL ION LEVELS. UPON REVISION SYNOVITIS AND GRAY COLORED FLUID WERE FOUND IN THE HIP. ALSO NOTED, CORROSION WAS FOUND ON THE FEMORAL NECK. THE FEMORAL STEM AND SLEEVE WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243103 SUMMIT POR TAPER SZ3 HI OFF STEM LPH DEPUY ORTHOPAEDICS, INC. B2XDP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR