BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO BIMETRIC STEM INSERTER

    MDR report key: 17469814 · Received August 7, 2023

    Report

    Report Number
    0001825034-2023-01826
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 12, 2023
    Report Date
    November 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    UDI-DI
    00880304466296
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 192512 ECHO POR FMRL RED LAT RPPNC 12X140 LOT NUMBER 65679278. 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. H3 OTHER TEXT : DEVICE IN PROCESS TO RETURN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN ECHO BIMETRIC STEM INSERTER WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE PART AND LOT OF THE INSERTER WERE VERIFIED TO MATCH THE COMPLAINT. VISUAL INSPECTION FOUND THE TIP OF THE THREADED SHAFT TO BE FRACTURED. THE FRACTURED PORTION WAS NOT RETURNED. RINGS OF WEAR ARE PRESENT AROUND THE THREADED SHAFT NEAR THE CENTER AND THE FRACTURE LOCATION. THE CONNECTOR OF THE THREADED SHAFT HAS BEEN DINGED AND SCRATCHED. THE STRIKE PLATE SHOWS SIGNS OF BEING IMPACTED. THE OPENING IN THE HANDLE THAT RECEIVES THE STRIKE PLATE IS SCRATCHED AND DINGED. THE CHANNEL IN THE INSERTER'S SHAFT HAS BEEN DINGED. SCUFFING CAN BE SEEN INSIDE THE CHANNEL. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    IT WAS REPORTED THAT THE ECHO BIMETRIC STEM INSERTER THREADS SHEARED OFF OF THE STEM IMPLANT DURING IMPACTING. THE PROCEDURE WAS COMPLETED USING ANOTHER STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223158 ECHO BIMETRIC STEM INSERTER INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A 105850 00880304466296

    Patients

    Seq Age Sex Outcome Treatment
    1 Male PLEASE SEE H10