BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 3010801 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-03395
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    June 17, 2008
    Report Date
    April 21, 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. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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 HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: COMPONENT LOOSENING - ACETABULAR CUP; PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114162 CORAIL2 STD SIZE 12 HIP STEM MEH DEPUY FRANCE 2327330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention