BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ4 STD OFF

    MDR report key: 4233791 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31388
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.(B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, DIFFICULTY WALKING, VERTIGO, DIFFICULTY SLEEPING, ELEVATED LEVELS OF CHROMIUM AND COBALT, A METAL TASTE IN HER MOOUTH, PSEUDOTUMOR, AND METAL SHOAVINGS AROUND THE IMPLANT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715264 SUMMIT DUOFIX TAP SZ4 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. - 1818910 BN2F8B000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other