BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 3953228 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06331
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 24, 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
    FI
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN; PMA/510(K) NUMBER/ MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO UNKNOWN REASONS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431212 UNKNOWN HEAD PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R