BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2884638 · Received December 24, 2012

    Report

    Report Number
    1818910-2012-25690
    Event Type
    Injury
    Date Received
    December 24, 2012
    Date of Event
    March 18, 2014
    Report Date
    November 5, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE INVESTIGATION 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.

    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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN BLOOD AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: 3/18/2014 - SALES REP REPORTED REVISION SURGERY. REASON FOR REVISION NOT PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE REC 11/05/2014 - PLAINTIFF PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. 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: 12/04/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2533915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other