BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 11

    MDR report key: 2111535 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08567
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    July 25, 2010
    Report Date
    April 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LWJ
    PMA / PMN Number
    K042992
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (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

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON THE RIGHT SIDE. ON (B)(6) 2010, X-RAYS WERE TAKEN OF THE PATIENT'S RIGHT HIP. THE X-RAYS INDICATED THAT THE ACETABULAR COMPONENT OF THE ASR HIP HAD ROTATED APPROXIMATELY 90 DEGREES, THAT THERE WAS LOOSENING OF THE ASR HIP, AND THAT THE ASR HIP NEEDED TO BE REPLACED. ON OR ABOUT (B)(6) 2010, SURGEON REMOVED THE ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT COLLAR SIZE 11 87KWA; 87L20; 87MEH; 87LWJ LWJ DEPUY INTERNATIONAL, LTD. NA 2347357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention