BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 3903829 · Received June 30, 2014

    Report

    Report Number
    1818910-2014-22331
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    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 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

    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.

    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, STEM LOOSENING, ACETABULAR CUP LOOSENING AND PSEUDOTUMOR FROM METAL ON METAL HIP ARTHROPLASTY. UPON REVISION, CORROSION AT THE FEMORAL HEAD/TRUNNION JUNCTION AND A SMALL CRACK IN THE TROCHANTER WERE NOTED.

    Description of Event or Problem · 1

    UPDATE REC'D 6/27/2014 - LITIGATION RECEIVED. LITIGATION ALLEGES STIFFNESS, DISCOMFORT, WEAKNESS AND ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 07/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380996 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2112731

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention