BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 3882229 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21456
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 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

    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. WWCAPA (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

    LITIGATION ALLEGES ELEVATED METAL ION LEVELS, DIFFICULTY AMBULATING AND PAIN.

    Description of Event or Problem · 1

    LITIGATION ALLEGES ELEVATED METAL ION LEVELS, DIFFICULTY AMBULATING AND PAIN.UPDATE DER RCVD - CONFIRMED DOI ((B)(6) 2008) AND DOR ((B)(6) 2014). ADDED SURGEON AND SALES REP DETAILS, ALSO ADDED PATIENT DOB. UPDATED THE CUP AND HEAD FROM UNKNOWN PRODUCTS AND ADDED SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358676 ASR ACETABULAR CUPS 56 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2452964

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R