BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3073672 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-02872
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    February 2, 2015
    Report Date
    March 18, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE BLOOD LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE BLOOD LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE: (B)(6) 2013 - 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.

    Description of Event or Problem · 1

    UPDATE REC'D 3/18/2015 - PPD WITH MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS METALLOSIS. UPON REVISION, EFFUSION, BLOOD TINGED CLEAR SYNOVIAL FLUID, AND GRAYISH BROWNISH STAINING OF THE SYNOVIUM WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 03/26/2015.

    Description of Event or Problem · 1

    UPDATE 2 FEB 2015 - ADDED PAIN AS A REASON FOR REVISION AND ADDED STEM AND SLEEVE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173325 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2903840

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R