BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3243955 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21965
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    September 20, 2013
    Report Date
    February 19, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    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. CORRECTED INFORMATION IMPLANT DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATON CLOSED.

    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.

    Description of Event or Problem · 1

    UPDATE 02/19/2014 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS IDENTIFIED THE DOB AND THE DOI, WHICH WILL BE UPDATED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THE INFORMATION RECEIVED DOES NOT AFFECT THE MDR DECISION. COMPLAINT WAS UPDATED ON 03/06/2014.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED AT THEIR OWN REQUEST. PART AND LOT HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342764 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2160621

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other