BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3851944 · Received June 5, 2014

    Report

    Report Number
    0001825034-2014-05277
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 13, 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
    TX, 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 1993. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO POLY WEAR. THE POLYETHYLENE LINER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328539 UNKNOWN HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R