BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUP 56

    MDR report key: 2831779 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-25019
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    March 9, 2015
    Report Date
    June 1, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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 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

    (B)(4) - PPD RECEIVED. PART/LOT FOR THE RIGHT AND LEFT HIPS HAVE BEEN UDPATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 6/1/2015 - MEDICAL RECORDS RECEIVED FOR RIGHT HIP REVISION FROM LEGAL. UPON REVISION, SYNOVITIS, OSTEOLYSIS AND CORROSION ON THE TRUNNION WERE NOTED. THE STEM REMAINED IN SITU. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON 06/17/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUP 56 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2227240

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other