BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, HIP

    MDR report key: 2780242 · Received October 10, 2012

    Report

    Report Number
    0001825034-2012-01880
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. DATE OF EVENT - UNKNOWN. INFORMATION PROVIDED IS UNCLEAR. BRAND NAME AND DEVICE PRODUCT CODE - UNKNOWN. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. PMA/510(K) NUMBER; MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    EVENT WAS REPORTED BY SURGEON AND NOT PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, PATIENT ALLEGES DECREASED BONE DENSITY IN THE TROCHANTERIC AREA. IT IS UNKNOWN WHETHER A REVISION PROCEDURE HAS OCCURED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention