BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2616730 · Received June 14, 2012

    Report

    Report Number
    1818910-2012-14988
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    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
    NY, 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CORRECTED: CATALOG #. ADDED: BRAND NAME, COMMON DEVICE NAME, LOT #, PMA/510(K) #, IF FOLLOW-UP, WHAT TYPE, MANUFACTURE DATE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED PAST AND FUTURE MEDICAL EXPENSES, ATTORNEYS FEES AND COSTS, PAIN AND SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF FUNCTION, USE AND RANGE OF MOTION, DECREASED AND POOR HIP PERFORMANCE AND LONGEVITY, GAIT DISTURBANCE, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND THE BODY, EXACERBATION OF UNDERLYING HIP JOINT DISORDERS, INTERNAL SCARRING, AND IRRITATION AND INJURY TO THE TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, BONES AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2141304

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention