BEUDAMED
    FDA Adverse Event Death Summary report: N

    WAGNER SL REVISION Ø14/190

    MDR report key: 5086594 · Received September 18, 2015

    Report

    Report Number
    9613350-2015-01098
    Event Type
    Death
    Date Received
    September 18, 2015
    Date of Event
    September 5, 2015
    Report Date
    September 5, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT DIED DURING AN IMPLANTATION OF A VERSYS HEAD AND A WAGNER SL REVISION STEM. THE SURGEON CLAIMED THAT THE IMPLANTATION OF THE COMPONENTS DID NOT CAUSE THE DEATH BUT THAT INTERNAL BLEEDING AND DROP OF BLOOD PRESSURE, MOST PROBABLY DUE TO A SEVERE ACCIDENT, WERE THE CAUSES FOR THE DEATH OF THE PATIENT. DHR REVIEW RESULTS: WAGNER SL REVISION Ø14/190, REF: 01.00101.914, LOT: 2743678, YIELD: 30, DELIVERED: 30, SCRAPPED: 0. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATED THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND WAS IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. IT COULD BE ASSUMED THAT THE WAGNER REVISION STEM DID NOT CORRELATE WITH THE DEATH OF THE PERSON SINCE THE PATIENT WAS ALREADY HEAVILY INJURED. IN ADDITION, THE SURGEON MENTIONED THAT THE PATIENT DIED DUE TO INTERNAL BLEEDING AND DROP OF BLOOD PRESSURE, UNRELATED TO THE IMPLANTS. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE DFMEA OF THE REPORTED DEVICE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2015 A PATIENT DIED ON OT TABLE. THE SURGEON WAS IMPLANTING A WAGNER SL REVISION Ø14/190 ON THE RIGHT SIDE, WHEN THE PATIENT HAD A FALL IN BLOOD PRESSURE WHICH WAS CONTROLLED AFTER ANAESTHESIA. AS PER DOCTOR, PATIENT DEATH WAS DUE TO INTERNAL BLEEDING AND FALL IN BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618572 WAGNER SL REVISION Ø14/190 WAGNER REVISIONAL FEMORAL HIP PROSTHESIS JDI ZIMMER GMBH NA 2743678

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death