BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS

    MDR report key: 6289262 · Received January 31, 2017

    Report

    Report Number
    0002648920-2017-00041
    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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS IS 4 OF 5 REPORTS BEING SUBMITTED FOR THE SAME PATIENT (REFERENCE 1822565-2017-00390 / 00392, 2648920-2017-00040 / 00041 / 00042).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    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
    74080 LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 62831897

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| O