BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 9

    MDR report key: 4000114 · Received August 11, 2014

    Report

    Report Number
    1818910-2014-25370
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    March 7, 2013
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICES ASSOCIATED WITH THIS COMPLAINT WERE NOT RETURNED. A WORLDWIDE COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED COMPLAINTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE METAL HEAD AND POLY LINER PROVIDED PRODUCT AND LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. 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 INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    **UPDATE RECEIVED 12/16/15. THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS FEMORAL STEM LOOSENING AND PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN. UPDATE: (B)(4) 2013, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE REC'D (B)(4) 2013 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. THE LEFT HIP WAS REVISED ON (B)(6) 2013 FOR METALLOSIS WHICH WAS CONFIRMED WITH THE REVISION OPERATIVE NOTE. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT ACTUALLY HAD A POLY INSERT IMPLANTED ON THE RIGHT HIP SO THE CUP, SCREW, AND STEM ARE BEING ADDED TO THE COMPLAINT AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF THE PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 8/11/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474763 CORAIL2 NON COL HO SIZE 9 HIP FEMORAL STEM KWA 3003895575 DEPUY FRANCE S.A.S 2769804

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other