BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ9 STD OFF

    MDR report key: 2914955 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00646
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    June 7, 2012
    Report Date
    December 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE SIGNIFICANT AND PERMANENT PERSONAL INJURY INCLUDING BUT NOT LIMITED TO THE RELEASE OF METAL AND/OR METAL IONS INTO HER BODY TISSUES AND BLOOD, PAIN, DISTRESS, ANXIETY, LIMITATION OF MOVEMENT, MEDICAL AND OTHER EXPENSES AND LOST WAGES OR LOST EARNING CAPACITY. (B)(4) 2011 - NEW LITIGATION PAPERS RECEIVED. THEY PROVIDED INFORMATION THAT ALLOWED US TO FIND AN INVOICE. HEAD AND CUP WERE ADDED. MEDWATCHES HAVE BEEN UPDATED. (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE CORROSION WAS FOUND UPON REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22200 SUMMIT DUOFIX TAP SZ9 STD OFF STEM LPH DEPUY INTERNATIONAL W3LE3A001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR