BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RADIAL HEAD

    MDR report key: 3033744 · Received April 3, 2013

    Report

    Report Number
    0001825034-2013-00828
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    July 14, 2009
    Report Date
    March 8, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE COMPONENTS IMPLANTED ON (B)(6) 2009 AND REVISED ON (B)(6) 2009 WERE COMPETITOR COMPONENTS. THIS MEDWATCH CAN BE VOIDED AS THERE WAS NO ISSUE WITH A BIOMET PRODUCT IN RELATION TO THE REVISION ON (B)(6) 2009.

    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. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER / MANUFACTURE DATE - UNKNOWN. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00828 / 00829).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON (B)(6) 2009 RECEIVING A COMPETITOR ELBOW. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF IMPLANTS FALLING APART AND BIOMET COMPONENTS WERE IMPLANTED. A REVIEW OF INVOICE HISTORY CONFIRMED THAT A STEM AND HEAD WERE IMPLANTED DURING THE REVISION. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON ON (B)(6) 2012. PATIENT ALLEGES THAT THE CURRENT SURGEON STATED THE ELBOW DEVICES REMOVED WERE TOO LARGE AND HAD WORN AWAY SOME OF HER BONE. PATIENT FURTHER ALLEGES THAT ALL COMPONENTS WERE REMOVED AND NO OTHER DEVICES WERE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF IMPLANTS FALLING APART. A REVIEW OF INVOICE HISTORY CONFIRMED THAT A STEM AND HEAD WERE IMPLANTED DURING THE REVISION. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON ON (B)(6) 2012. PATIENT ALLEGES THAT THE CURRENT SURGEON STATED THE ELBOW DEVICES REMOVED WERE TOO LARGE AND HAD WORN AWAY SOME OF HER BONE. PATIENT FURTHER ALLEGES THAT ALL COMPONENTS WERE REMOVED AND NO OTHER DEVICES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136608 UNKNOWN RADIAL HEAD PROSTHESIS, HIP KWI BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R