BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3892781 · Received June 24, 2014

    Report

    Report Number
    1818910-2014-21843
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    February 24, 2015
    Report Date
    April 7, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.(B)(4)

    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

    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 ALLEGES PAIN, DISCOMFORT, DIFFICULTY AMBULATING, FATIGUE, IRRITABILITY, ELEVATED METAL ION LEVELS, DISABILITY, AND SCARRING AND DISFIGUREMENT.

    Description of Event or Problem · 1

    UPDATE REC'D 09/24/2014- PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FROM PATIENT STICKER SHEET. 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: 10/13/2014.

    Description of Event or Problem · 1

    UPDATE 09 MAR 2015, DER AND INVOICE RECEIVED REASON FOR REVISION UPDATED TO METAL IONS, DOR (B)(6) 2015, CUP, STEM AND SLEEVES WERE NOT REVISED AS PER DER.

    Description of Event or Problem · 1

    UPDATE REC'D 4/7/2015 - MEDICAL RECORDS RECEIVED FROM LEGAL. UPON REVISION, FLUID AND METALLOSIS 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
    368727 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 2870836

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R