BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORAIL AMT COLLAR SIZE 15

    MDR report key: 3933425 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23350
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    July 9, 2012
    Report Date
    July 1, 2014
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED FOR EACH OF THE PROVIDED PRODUCT LOT CODES. THE REVIEWS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND INFLAMMATION. LITIGATION ALSO ALLEGES THE PATIENT DIED DUE TO AN ISCHEMIC STROKE AFTER HAVING UNRESPONSIVENESS AFTER HIS SURGERY. UPDATE REC'D (B)(4) 2014- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED A LOOSE STEM SO THE STEM IS BEING ADDED THE COMPLAINT. THE REVISION OPERATIVE NOTE ALSO INDICATED THERE WAS NO METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409666 CORAIL AMT COLLAR SIZE 15 HIP OTHER IMPLANT KWA DEPUY FRANCE SAS - 3003895575 2497569

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention