BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3851978 · Received June 5, 2014

    Report

    Report Number
    0001825034-2014-05278
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    August 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
    ND, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN, DATE IMPLANTED - UNKNOWN, PMA/510(K) NUMBER, MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. A REVISION PROCEDURE WILL NOT OCCUR BECAUSE PATIENT DOES NOT BELIEVE PAIN IS RELATED TO IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED IN 1999 DUE TO AN UNKNOWN REASON. A SECOND REVISION PROCEDURE HAS BEEN INDICATED ALLEGEDLY DUE TO PAIN; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328990 UNKNOWN HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R