BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2233800 · Received September 4, 2011

    Report

    Report Number
    1818910-2011-17204
    Event Type
    Injury
    Date Received
    September 4, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 9, 2011
    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
    TN, US
    Reporter Occupation
    PATIENT

    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 (B)(4) 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.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED. INTRAOPERATIVELY AN ABUNDANT AMOUNT OF CLOUDY DARK FLUID CAME OUT UNDER PRESSURE. THE SURGEON FELT THE PATIENT HAD A REACTION TO METAL-ON-METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2382856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention