BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 13

    MDR report key: 2111480 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08124
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    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. WWCAPA (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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS AND PAIN. THE FEMORAL STEM WAS LOOSE WITH FIBROUS INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 NON COL HO SIZE 13 87KWA 87LZO 87MEH 87LWJ KWA DEPUY FRANCE S.A. NA 1991915

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention