BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3141162 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18011
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 19, 2014
    Report Date
    July 15, 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
    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. 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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGES PAIN, DIFFICULTY AMBULATING, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    UPDATE REC'D 7/15/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, METALLOSIS MATERIAL AND CORROSION ON THE TRUNNION, A LARGE PSEUDOTUMOR, AND LOSS OF THE ANTERIOR WALL OF THE ACETABULUM WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THE STEM REMAINED IN SITU. UPDATE REC'D: 9/15/2014 CLINICAL REPORT RECEIVED. PATIENT EXPERIENCED INFECTION AND INFLAMMATION. PART/LOT INFORMATION PROVIDED. THIS COMPLAINT WAS UPDATED ON: 10/02/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243200 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2764862

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other