BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3093277 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-05358
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 18, 2018
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    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

    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

    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

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND INHIBITION OF ABILITY TO WALK AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    **UPDATE** 2/18/2014- PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED SIDE, DOB, AND PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES METAL DEBRIS AND INJURY. CORRECTED PATIENT IDENTIFIER. DOI: (B)(6) 2007 - DOR: NONE REPORTED (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196656 ASR UNI FEMORAL IMPL SIZE 51 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS KWA DEPUY INTERNATIONAL LTD - 8010379 2212979

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other