BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 3013128 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-03437
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. REF. (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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC 720-2013 REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES PATIENT HAD SEVERE AND CONSTANT PAIN, ELEVATED METAL LEVELS, TISSUE DAMAGE, SYNOVIAL FLUID BUILD-UP AND LACK OF MOBILITY AFTER ASR HIP IMPLANT. DOI: (B)(6) 2009 (RIGHT HIP) DOR: NONE REPORTED THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD SEVERE AND CONSTANT PAIN, ELEVATED METAL LEVELS, TISSUE DAMAGE, SYNOVIAL FLUID BUILD-UP AND LACK OF MOBILITY AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE - ADDED A STEM FROM INVOICE PREVIOUSLY MISSED. SEE EMAIL DATED 16TH APRIL 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115055 ASR UNI FEMORAL IMPL SIZE 41 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2716547

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R