BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 3163214 · Received June 11, 2013

    Report

    Report Number
    0001825034-2013-01913
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP PROCEDURE ON AN UNKNOWN DATE IN 2000. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO WEAR OF THE LINER. THE LINER WAS REPLACED WITH A BIOMET LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263510 UNKNOWN LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R