BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3183375 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19601
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    October 9, 2014
    Report Date
    February 9, 2015
    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
    TX, 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. (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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, SORENESS, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. ALSO ALLEGED FLUID COLLECTION AT THE POSTERIOR GREATER TROCHANTER AND A SEPARATE FLUID COLLECTION BETWEEN THE GLUTEUS MEDIUS AND GLUTEUS MAXIMUS MUSCLE BODIES.

    Description of Event or Problem · 1

    UPDATE REC'D 02/09/2015 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOI 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: 03/02/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283452 ASR UNI FEMORAL IMPL SIZE 51 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. - 8010379 3015169

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other