BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP PRIMARY STEM 16MM MINI

    MDR report key: 15642302 · Received October 20, 2022

    Report

    Report Number
    0001825034-2022-02014
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    June 7, 2022
    Report Date
    August 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00887868267833
    PMA / PMN Number
    K060692
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: CATALOG #: 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT # 334840, CATALOG #: 405889, COMP RVS 2.7MM DIA DRL, LOT # 364060, CATALOG #: 405883, COMP RVS 3.2MM DRL, LOT # 665020, CATALOG #: 113034, VERSA-DIAL 42X21X43 HUM HEAD, LOT # J7156453, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # J7073921, CATALOG #: 110035767, COMP CONV GLEN LINER VIVACIT-E, LOT # 65163941, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 126250, CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 125830, CATALOG #: 115395, COMP RVS CNTRL 6.5X25MM ST/RST, LOT # 182620, CATALOG #: 110005273, COMP CNV GLEN BASE NON HA, LOT # 112850, AND CATALOG #: 113635, COMP PRIMARY STEM 15MM MINI, LOT # 65301005. REPORTED EVENT WAS NOT CONFIRMED AS VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED STEM REVEALS COSMETIC SCRATCHES ON THE DISTAL END, AROUND THE COLLAR FACE, AND NICKS ALONG THE EDGES OF THE POROUS COATING. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE POROUS COATED AREA AND OVERALL LENGTH AND FOUND TO BE CONFORMING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO NO PROBLEM FOUND AS THE RETURNED DEVICE WAS FOUND TO HAVE CONFORMING MEASUREMENTS. 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 · 0

    IT WAS REPORTED THAT THE PATIENT WAS REAMED AND BROACHED TO 16MM AND THE 16MM STEM WOULD NOT FULLY SEAT. IT WAS STATED THAT THE STEM WAS 1-2MM PROUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059892 COMP PRIMARY STEM 16MM MINI EXTREMITIES IMPLANTS HSD ZIMMER BIOMET, INC. N/A 65095341 00887868267833

    Patients

    Seq Age Sex Outcome Treatment
    1 Female