BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 3884424 · Received June 19, 2014

    Report

    Report Number
    0001825034-2014-05653
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 22, 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
    US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN SUGGESTED DUE TO POSSIBLE ACETABULAR CUP MALPOSITIONING; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361695 UNKNOWN CUP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention