BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3127243 · Received May 23, 2013

    Report

    Report Number
    1818910-2013-05420
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    February 3, 2015
    Report Date
    April 7, 2015
    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
    AL, 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. NOT RECEIVED.

    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 STATE AFTER IMPLANT OF THE DEVICE PATIENT EXPERIENCED PAIN AND DISCOMFORT. UPDATE: (B)(6) 2012. PLAINTIFF'S FACT SHEET (PFS) RECEIVED (B)(6) 2012. CHANGED UNK ASR HIP TO ASR CUP ADDED FEMORAL HEAD.

    Description of Event or Problem · 1

    UPDATE REC'D 4/7/2015- MEDICAL RECORDS RECEIVED FROM LEGAL. DOR PROVIDED. PATIENT WAS REVISED TO ADDRESS A CYST. UPON REVISION, GRANULOMATOUS TISSUE AND OSTEOLYSIS WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON 04/16/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228754 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2718272

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R