BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 44MM M SPEC+8.5

    MDR report key: 2982363 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12912
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    June 12, 2012
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS RECEIVED FROM LEGAL. PFS ALLEGES THAT THE PATIENT SUFFERS FROM ELEVATED LEVELS OF COBALT CHROMIUM.

    Description of Event or Problem · 1

    PPF ALLEGES METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88145 12/14 ARTICUL 44MM M SPEC+8.5 TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS, INC. 1818910 2446716

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention