BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 10

    MDR report key: 3073139 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-04968
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 1, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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).

    Description of Event or Problem · 1

    ASR REVISION, HIP(S) REVISED: LEFT, TYPE OF HIP REPLACEMENT PRODUCT: ASR XL ACETABULAR SYSTEM; REASON(S) FOR REVISION: PAIN AND COMPONENT LOOSENING - STEM.

    Description of Event or Problem · 1

    THE RIGHT HIP OF THE PATIENT WAS REVISED, NOT THE LEFT HIP AS PREVIOUSLY REPORTED. IN ADDITION, THE COMPONENT THAT LOOSENED WAS THE ACETABULAR CUP, NOT THE STEM AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173548 CORAIL2 STD SIZE 10 STEM MEH DEPUY FRANCE 2386399

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention