BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR LINER

    MDR report key: 4061182 · Received September 4, 2014

    Report

    Report Number
    0001825034-2014-07522
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO WEAR OF THE POLYETHYLENE ACETABULAR LINER. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541273 UNKNOWN ACETABULAR LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R