BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 3082527 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-05147
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    September 29, 2008
    Report Date
    April 18, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    MEH
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. REF. (B)(4).

    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

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE RIGHT HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183183 CORAIL2 STD SIZE 11 HIP STEM MEH DEPUY FRANCE 1820711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention