BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 10

    MDR report key: 3093646 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-05531
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    March 29, 2011
    Report Date
    March 17, 2015
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    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

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: UNKNOWN. (B)(6). LOT NO FOR CUP UNKNOWN. ADDED COUNTRY 09 MAY 2013. UPDATE - ADDED REASON FOR REVISION, FILE HANDLER DETAILS, HOSPITAL, ADDITIONAL SURGEON, LOT NUMBER FOR CUP, ADDED HEAD BUT QUERYING INCORRECT LOT NUMBER FOR HEAD. TAKEN FROM CLAIMSUITE DATED 17TH MARCH 2015. REASON(S) FOR REVISION: PAIN, HOSPITAL: (B)(6), ADDITIONAL SURGEON - (B)(6), LOT NUMBER FOR CUP - 2459077. CORRECT LOT FOR HEAD NOW RECEIVED ON 19TH MARCH 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195899 CORAIL2 STD SIZE 10 HIP FEMORAL STEM/SLEEVE MEH DEPUY FRANCE SAS 3003895575 2421662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention