BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2071331 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-06239
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    July 29, 2010
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040267
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, LOT #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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). ADDITIONAL LITIGATION PAPERS ALLEGE PATIENT HAD PAIN, BONE AND TISSUE DAMAGE AND EXPOSURE TO ELEVATED LEVELS OF COBALT AND CHROMIUM AFTER ASR HIP IMPLANT. DEPUY STILL 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 PAPERS ALLEGE PT BEGAN EXPERIENCING SYMPTOMS, INCLUDING, BUT NOT LIMITED TO, PAIN AND LOSS OF MOBILITY, AND SUFFERING FROM LOSS OF ENJOYMENT OF LIFE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT BEGAN EXPERIENCING SYMPTOMS, INCLUDING, BUT NOT LIMITED TO, PAIN AND LOSS OF MOBILITY, AND SUFFERING FROM LOSS OF ENJOYMENT OF LIFE. UPDATE: (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THE PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. INTRAOPERATIVELY THERE WS A LARGE AMOUNT OF CLOUDY, METAL-STAINED FLUID WITHIN THE JOINT. THE COMPLAINT WAS TEMPORARILY REOPENED TO ADD THE FEMORAL HEAD. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2012 - AMENDED LITIGATION PAPERS STATE: THE PATIENT SUFFERED AND CONTINUES TO SUFFER, SERIOUS BODILY INJURY, AND WAS FORCED TO UNDERGO REVISION SURGERY. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 48 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2178612

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention