BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SHELL INSERTER

    MDR report key: 11928629 · Received June 3, 2021

    Report

    Report Number
    0001822565-2021-01518
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    October 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D9; G3; H2; H3; H6. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE STRAIGHT SHELL INSERTER IDENTIFIED THE FOLLOWING: THE THREADED TIP IS FRACTURED AND THE FRACTURED PIECE HAS NOT BEEN RETURNED. THE DEVICE EXHIBITS WEAR AND TEAR CONSISTENT WITH USE OVER A POTENTIAL FIELD AGE OF APPROXIMATELY 7 YEARS. NO OTHER DAMAGE WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORDS AND RECEIVING INSPECTION REPORTS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED FAILURE HAS BEEN PREVIOUSLY INVESTIGATED BY ZIMMER BIOMET IN QIR 11113. PER THE QIR, THREADED BOLT TIP FRACTURE- THE FAILURE MODE OCCURS MOST FREQUENTLY WHEN THE STRAIGHT SHELL INSERTER IS PAIRED WITH THE CONTINUUM OR TRILOGY IT SHELL. THE LEVERING FORCE PUTS GREAT STRESS ON THE DISTAL END OF THE BOLT AND ITS INTERFACE WITH THE SHELL THREADS. INITIALLY, DUE TO DIFFERENCE IN THE MATERIAL PROPERTIES, THE TITANIUM THREADS OF THE SHELL WILL YIELD BEFORE THE STAINLESS STEEL THREADS OF BOLT, BUT THE SHELL IS SINGLE USE SO THAT IS ACCEPTABLE. HOWEVER, AFTER REPETITIVE CYCLIC LOADING, FATIGUE EFFECTS ACCUMULATE FOR THE BOLT AND CAUSE THE TIP TO FRACTURE. 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE (B)(6). PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIP PROCEDURE, THE IMPACTOR WAS HIT WITH A MALLET WITH EXTREME FORCE CAUSING THE TIP TO BREAK OFF IN THE PATIENT. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE IMPLANT WAS UNHARMED AND STAYED IMPLANTED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824675 STRAIGHT SHELL INSERTER HIP INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 62656893

    Patients

    Seq Age Sex Outcome Treatment
    1