BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP COMPONENTS

    MDR report key: 3011303 · Received March 19, 2013

    Report

    Report Number
    0001825034-2013-00644
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS A RESULT: PRODUCT IDENTIFICATION/EXPIRY DATE. DATE IMPLANTED - APPROXIMATELY 20 YEARS AGO, EXACT DATE OF IMPLANTATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY APPROXIMATELY TWENTY YEARS AGO. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO WEAR. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113659 UNKNOWN HIP COMPONENTS PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R