BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2213234 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14962
    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

    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

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    BILATERAL PT - LITIGATION PAPERS ALLEGE IN OR AROUND APPROX 2008, PT BEGAN EXPERIENCING SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, LOSS OF MOBILITY AND LOSS OF ENJOYMENT OF LIFE. ON OR AROUND (B)(6) 2011, PT IS SCHEDULED TO UNDERGO REVISION SURGERY FOR HER LEFT HIP. APPROX THREE TO SIX MONTHS AFTER REVISION OF HER LEFT HIP, PT WILL BE SCHEDULED TO UNDERGO REVISION SURGERY FOR HER RIGHT HIP.

    Description of Event or Problem · 1

    BILATERAL PATIENT - LITIGATION PAPERS ALLEGE IN OR AROUND APPROXIMATELY 2008, PATIENT BEGAN EXPERIENCING SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, LOSS OF MOBILITY AND LOSS OF ENJOYMENT OF LIFE. ON OR AROUND (B)(6) 2011, PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY FOR HER LEFT HIP. APPROXIMATELY THREE TO SIX MONTHS AFTER REVISION OF HER LEFT HIP, PATIENT WILL BE SCHEDULED TO UNDERGO REVISION SURGERY FOR HER RIGHT HIP. UPDATE: (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. PRODUCT CODES FOR THE LEFT HIP WERE IDENTIFIED. THE LEFT HIP WAS REVISED DUE TO PAIN. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE RIGHT SIDE. PATIENT WAS REVISED DUE TO PAIN AND HIGH METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 48 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2064570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention