BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 2931675 · Received January 28, 2013

    Report

    Report Number
    1818910-2013-02208
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    November 10, 2014
    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
    CA, 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. REF. (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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: SUFFERED FROM PAIN AND DISCOMFORT IN HIS LEFT HIP. IT BECAME INCREASINGLY PAINFUL FOR HIM TO WALK, TO MOVE HIS LEGS AND TO RISE FROM A SEATED POSITION. **UPDATE** 2/7/12 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, CORRECT IMPLANT DATE AND DATE OF EXPLANT. 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 11/10/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS METAL HYPERSENSITIVITY. UPON REVISION, ACETABULAR LOOSENING, CLOUDY YELLOW SYNOVIAL FLUID, AND GRAY-BROWN STAINED SOFT TISSUE WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 12/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37991 ASR UNI FEMORAL IMPL SIZE 55 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2123432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other