BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2994077 · Received March 8, 2013

    Report

    Report Number
    1818910-2013-13424
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    July 23, 2014
    Report Date
    December 3, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (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.(B)(4)

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FORM PAIN, WEAKNESS, FATIGUE, ELEVATED LEVELS OF CHROMIUM AND COBALT, METALLOSIS, INSTABILITY OF CONTRA LATERAL HIP, GAIT CHANGES, BONE AND MUSCLE DETERIORATION.

    Description of Event or Problem · 1

    UPDATE REC¿D 12/3/2014 - PPD WITH FIRST PAGE OF REVISION MEDICAL RECORDS RECEIVED. DOR AND PART/LOT INFORMATION RECEIVED AND UPDATED. POST OPERATIVE DIAGNOSIS OF ADVERSE TISSUE REACTION NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT FOR ELEVATED METAL ION LEVELS. STEM REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99777 ASR ACETABULAR CUPS 60 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 2541013

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R