BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO BIMETRIC STEM INSERTER

    MDR report key: 7222234 · Received January 26, 2018

    Report

    Report Number
    0001825034-2018-00301
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    December 19, 2017
    Report Date
    November 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE FRACTURED TIP OF THE INSERTER IS STILL ENGAGED WITH THE THREADS OF THE SHELL. ADDITIONAL DAMAGE TO THE FRACTURED TIP CAN BE SEEN ON THE OUTER RADIUS OF THE SHELL. THE INSERTER CONFIRMED THAT THE THREADED TIP OF THE STANDARD ROD IS FRACTURED. DISCOLORATION, CORROSION, AND WEAR MARKS WERE OBSERVED ON THE STANDARD ROD. THE STRIKE PLATE AND SHAFT OF THE INSERTER EXHIBIT STRIKE MARKS, SCRATCHING AND GOUGING CONSISTENT WITH REPEATED USE OVER THE COURSE OF THE INSTRUMENT LIFETIME. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: 14-103648, RINGLOC UNIV 2-HOLE SHL 48MM, 184450; UNKNOWN, UNKNOWN INSERTER, UNKNOWN. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00444, 0001825034 - 2018 - 00300.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT HIP PROCEDURE THE TIP OF THE INSERTER FRACTURED AND BECAME LODGED IN THE SHELL. THE SURGEON HAD TO REMOVE THE SHELL AND INSERT A NEW ONE CAUSING A DELAY IN THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65543 ECHO BIMETRIC STEM INSERTER SURGICAL, INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 455130

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention