BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3882557 · Received June 19, 2014

    Report

    Report Number
    1818910-2014-21485
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    November 4, 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
    CA, 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. 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. 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).

    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 AND INJURY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, DISCOMFORT AND INJURY. UPDATE REC'D 10/08/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/06/2014. UPDATE REC'D 10/31/2014- MEDICAL RECORDS RECEIVED. DOR PROVIDED. UPON REVISION, GRAY CLOUDY FLUID, SYNOVITIS, AND NO BONY INGROWTH ON THE CUP WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: 11/25/2014.

    Description of Event or Problem · 1

    UPDATE REC 11/04/2014 - PLAINTIFF 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: 12/04/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 10/08/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/06/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361853 ASR UNI FEMORAL IMPL SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2185138

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R