BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2894206 · Received January 3, 2013

    Report

    Report Number
    1818910-2013-00202
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    April 29, 2013
    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
    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

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED DEBILITATING PAIN AND DISCOMFORT IN HIPS AND LEGS, THEREBY INTERFERING WITH HER ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 - PATIENTS REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. UPON REVISION A LARGE PSEUDOTUMOR, GRAY MILKY COLORED FLUID, AND DISSOCIATION OF THE GLUTEUS MEDIUS TENDON ONTO THE TROCHANTER WAS FOUND. THERE WAS AN INSIGNIFICANT AMOUNT OF CORROSION NOTED AT THE TRUNNION HEAD INTERFACE AND NO BONY INGROWTH OF THE ACETABULAR CUP. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT AND THE COMPLAINT REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2709308

    Patients

    Seq Age Sex Outcome Treatment
    1 Other