BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3062348 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-03155
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 11, 2014
    Report Date
    April 16, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 THE INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT EXPERIENCED PAIN AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM. HE HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.**UPDATE** (B)(6) 2011 PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Description of Event or Problem · 1

    UPDATE REC'D 04/16/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION BROWNISH STAINING ALONG THE SYNOVIUM WAS FOUND. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    UPDATE: 2/11/2014: SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED DUE TO: "THERE WERE NO MEDICAL ISSUES WITH THE ASR. ALL WAS FINE BUT THE PATIENT INSISTED HE WANTED IT REVISED. IT WAS A PSYCHOLOGICAL ISSUE." THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 02/26/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162551 ASR UNI FEMORAL IMPL SIZE 47 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2706356

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other