BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHELL 46 MM O.D.

    MDR report key: 6289266 · Received January 31, 2017

    Report

    Report Number
    0002648920-2017-00040
    Event Type
    Death
    Date Received
    January 31, 2017
    Date of Event
    October 15, 2015
    Report Date
    November 11, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    PMA / PMN Number
    PK833991
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AFTER RECEIVING A ZIMMER VERSYS HIP REPLACEMENT SYSTEM. THE PATIENT HAD A FITMORE HIP STEM. IT WAS LATER REPORTED THAT THE PATIENT DIED POST-IMPLANTATION FROM UNRELATED COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AFTER RECEIVING A ZIMMER VERSYS HIP REPLACEMENT SYSTEM. THE PATIENT HAD A FITMORE HIP STEM. IT WAS LATER REPORTED THAT THE PATIENT DIED POST-IMPLANTATION FROM UNRELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71741 SHELL 46 MM O.D. PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 62738211

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| O