BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3073413 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-03152
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    December 9, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.(B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN AND POPPING IN THE RIGHT HIP WHEN THE PATIENT BENDS OVER. ADDITIONALLY IT IS ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE 11/14/2011 PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Description of Event or Problem · 1

    UPDATE REC'D 11/21/2014 - PLAINTIFF铠PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 12/18/14.

    Description of Event or Problem · 1

    UPDATE REC'D 12/9/2014- MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS METALLOSIS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174925 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2783221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other