BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 3183148 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19551
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    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
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-19729. THIS REPORT, 18189-2013-19551, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-19729. 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

    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

    REVISION OPERATIVE REPORT STATES DURING THE REVISION, THE FOLLOWING WAS FOUND: A LARGE FLUID COLLECTION THAT WAS DARK BROWN AND TURBID, MODERATE FRETTING AND CORROSION ON THE STEM TAPER. **UPDATE** (B)(4) 2013 - LITIGATION PAPERS ALLEGE PAIN, PERMANENT INJURY AND ELEVATED METAL ION LEVELS. **UPDATE**(B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND DOB. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    REVISION OPERATIVE REPORT STATES DURING THE REVISION, THE FOLLOWING WAS FOUND: A LARGE FLUID COLLECTION THAT WAS DARK BROWN AND TURBID, MODERATE FRETTING AND CORROSION ON THE STEM TAPER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284002 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2463130

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention