BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 3924471 · Received July 9, 2014

    Report

    Report Number
    1818910-2014-23056
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    August 5, 2014
    Report Date
    February 10, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION 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. 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 (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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES ELEVATED METAL ION LEVELS, PERMANENT INJURIES, AND PAIN.

    Description of Event or Problem · 1

    UPDATE REC¿D 2/10/2015 - MEDICAL RECORDS RECEIVED. UPON REVISION, A LARGE DEEP BROWN TO BLACK COLORED EFFUSION, AND IRREGULAR APPEARING AND STAINED BURSA WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED FOR ELEVATED METAL ION LEVELS. THE STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON: 03/03/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401099 UNKNOWN DEPUY ASR ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R