BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 2548816 · Received April 25, 2012

    Report

    Report Number
    1818910-2012-08719
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    July 2, 2012
    Report Date
    April 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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). 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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT EXPERIENCED PAIN DUE TO ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY FOR THE RIGHT HIP. PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE REC'D 04/18/2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 05/13/2014.

    Description of Event or Problem · 1

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION ALLEGES PATIENT EXPERIENCED PAIN DUE TO ASR HIP IMPLANT. UPDATE: 7/2/12 - THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE LEFT SIDE. PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. UPDATE 11/05/2012 - CLINICAL REPORT STATES THE PATIENT WAS REVISED DUE TO METALLOSIS. UPDATE: 11/12/2012 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION FOR THE LEFT SIDE. NO NEW INFORMATION RECEIVED THAT WOULD CHANGE THE INVESTIGATIONAL RESULTS. UPDATE: 1/15/2014 - SALES REP REPORTED REVISION SURGERY FOR THE RIGHT HIP. PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE REC'D: 4/9/2014 - CLINICAL REPORT WITH STICKER SHEET RECEIVED FOR RIGHT HIP REVISION. DOI/DOR UPDATED FOR RIGHT HIP, DOR UPDATED FOR LEFT HIP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 05/08/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 41 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2383822

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other