BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 3882157 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21446
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    January 13, 2014
    Report Date
    August 28, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.(B)(4). 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 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.

    Description of Event or Problem · 1

    UPDATE REC'D 08/28/2014- LITIGATION PAPERS RECEIVED. THE DOI WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 09/11/2014.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO PAIN, ELEVATED METAL ION LEVELS, DISCOMFORT AND METALLOSIS. UPON REVISION, SYNOVITIS, METAL STAINED FLUID, DARK STAINED TISSUE, GRANULOMATOUS TISSUE AND A MOSTLY FIBROUS INGROWN CUP (OSSEOINTEGRATION OF 2CM SQ SECTION) WERE NOTED. LEGAL CLAIM WAS ALSO RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358604 UNKNOWN DEPUY ASR ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention