BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 36IDX58OD

    MDR report key: 4871215 · Received June 26, 2015

    Report

    Report Number
    1818910-2015-24475
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK001534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO NOTED ALL BUT TWO ARDS HAD SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416182 PINN MAR NEUT 36IDX58OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 208335

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention