BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 3801396 · Received May 8, 2014

    Report

    Report Number
    1818910-2014-18415
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 16, 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
    OH, 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 THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. 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. (B)(4). DEPUY CONSIDERS THIS 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 05/16/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, METAL STAINED FLUID AND GRANULOMATOUS TISSUE WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 06/05/2014.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. ASR REVISION REPORTED BY SALES REP. LEFT SIDE HIP. REASON(S)FOR REVISION: PAINFUL ASR CUP. REMOVED AND REPLACED WITH CERAMIC ON POLY, STEM LEFT IN PLACE. INVALID LOT NUMBER CY6D21000 PROVIDED FOR STEM, SO LEFT STEM LOT NUMBER AS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278535 ASR ACETABULAR CUPS 58 HIP ACETABULAR CUP KWA DEPUY INTL., LTD - 8010379 2573310

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other