BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3181556 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-04469
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    August 29, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: PATIENT EXPERIENCES EXCRUCIATING PAIN EVERY MINUTE OF THE DAY. CURRENTLY PATIENT IS FORCED TO TAKE PAIN MEDICATION INCLUDING MORPHINE EVERY SIX HOURS AS A RESULT IS CONSTANTLY DROWSY AND DYSFUNCTIONAL. BASED ON THESE CONDITIONS, PATIENTS DOCTORS WOULD RECOMMEND THAT HIS ASR HIP SYSTEM BE REVISED AND A NEW SYSTEM IMPLANTED. HOWEVER, GIVEN PATIENT'S HEART CONDITION, HIS DOCTORS HAVE CONCLUDED THAT HIP REVISION SURGERY WOULD POTENTIALLY KILL HIM AND HAVE THEREFORE ADVISED HIM HE MUST SIMPLY LIVE WITH THE EXCRUCIATING PAIN HE EXPERIENCES DAILY FOR THE REST OF HIS LIFE.

    Description of Event or Problem · 1

    UPDATE: 01/30/2017¿ SALES REP HAS REPORTED A REVISION DUE TO PAIN. ADDING THE SLEEVE TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282221 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2616104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other