BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 4172315 · Received October 15, 2014

    Report

    Report Number
    0001825034-2014-08129
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH:

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE IMPLANTING A UNI-POLAR HIP SYSTEM. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2014 DUE TO UNKNOWN REASONS. PATIENT WAS CONVERTED TO A PRIMARY TOTAL HIP SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE IMPLANTING A UNI-POLAR HIP SYSTEM. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNKNOWN REASONS. THE MODULAR HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653329 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R