BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 54

    MDR report key: 2071633 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06269
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 16, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    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

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT BEGAN TO SUFFER FROM SEVERE PAIN, AS WELL AS CLICKING, POPPING AND CRACKING IN HER HIP. IT IS FURTHER ALLEGED PATIENT HAS ELEVATED COBALT METAL IONS IN HER BLOOD STREAM. IT IS ADDITIONALLY ALLEGED DOCTORS HAVE ADVISED PATIENT THAT SHE WILL SHORTLY BE REQUIRED TO UNDERGO REVISION SURGERY. UPDATE: (B)(4) 2011 - SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO CUP LOOSENING AND SOFT TISSUE REACTION. UPDATE: (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. IT WAS NOTED THAT THERE WAS SOME CREVICE CORROSION PRESENT ON THE NECK, THE TAPER. THE COMPLAINT WAS REOPENED TO ADD THE ADAPTER SLEEVE AND FEMORAL STEM. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE SLEEVE AND LOT INFORMATION FOR THE ACETABULAR CUP. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT BEGAN TO SUFFER FROM SEVERE PAIN, AS WELL AS CLICKING, POPPING AND "CRACKING" IN HER HIP. IT IS FURTHER ALLEGED PATIENT HAS ELEVATED COBALT METAL IONS IN HER BLOOD STREAM. IT IS ADDITIONALLY ALLEGED DOCTORS HAVE ADVISED PATIENT THAT SHE WILL SHORTLY BE REQUIRED TO UNDERGO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 54 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2715380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention