BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER KINECTIV FEMORAL STEM

    MDR report key: 5535905 · Received March 30, 2016

    Report

    Report Number
    1822565-2016-00816
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 29, 2016
    Report Date
    September 11, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK063251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00784802300, M/L TAPER KINECTIV NECK, LOT #63175848 . THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: TM MODULAR CUP 54 MM CLUSTER CATALOG#: 00620205422 LOT#: 63187679, TRILOGY BONE SCREW 6.5X30 CATALOG#: 00625006530 LOT#: 63198746, BONE SCREW SELF-TAPPING CATALOG#: 00625006525 LOT#: 63231466, TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE CATALOG#: 00630505032 LOT#: 63186938, BIOLOX DELTA FEMORAL HEAD, 32 MM, +0 MM CATALOG#: 00877503202 LOT#: 2810666. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DESIGN HISTORY RECORDS WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. PHOTOGRAPHS OF THE FEMORAL HEAD, NECK AND STEM WERE PROVIDED; HOWEVER, NO CONCLUSION COULD BE DRAWN ABOUT THE DEVICES. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. INVESTIGATION CONCLUSION DETERMINED THE ROOT CAUSE OF THE BONE FRACTURE WAS THE PATIENT'S FALL. THERE ARE WARNINGS IN THE PACKAGE INSERT ABOUT THIS TYPE OF EVENT AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 IS REPORTED THE PATIENT WAS REVISED DUE TO FALLING AND FRACTURING HER LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190053 ZIMMER M/L TAPER KINECTIV FEMORAL STEM KWA KWA ZIMMER, INC. N/A 63044912

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention