BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2213265 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14963
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    UPDATE: (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. THE PATIENT WAS REVISED TO ADDRESS PAIN AND GRINDING. IT WAS NOTED THAT THERE WAS DIFFUSE METAL STAINING THROUGHOUT 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. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE (B)(4) IN (B)(4) 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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE IN OR AROUND APPROXIMATELY LATE 2009, PATIENT BEGAN EXPERIENCING SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PAIN, LOSS OF MOBILITY AND LOSS OF ENJOYMENT OF LIFE. IT IS ALSO ALLEGED ON OR AROUND (B)(6) 29, 2011, PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE IN OR AROUND APPROXIMATELY (B)(6) 2009, PATIENT BEGAN EXPERIENCING SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, LOSS OF MOBILITY AND LOSS OF ENJOYMENT OF LIFE. IT IS ALSO ALLEGED ON OR AROUND (B)(6) 2011, PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY. UPDATE: (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE PATIENT WAS REVISED TO ADDRESS PAIN AND GRINDING. IT WAS NOTED THAT THERE WAS DIFFUSE METAL STAINING THROUGHOUT 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 - 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 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2523798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention