BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SHELL INSERTER

    MDR report key: 8743642 · Received June 28, 2019

    Report

    Report Number
    0001822565-2019-02736
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 30, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS AND RECEIVING INSPECTION REPORT IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE ISSUE HAS BEEN PREVIOUSLY ADDRESSED IN QIR 11113. AS PER 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: SHELL WITH CLUSTER HOLES # ITEM 00875705001 LOT 64148297. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOCTOR WAS IMPLANTING CUP INTO PATIENT, THREADS FROM CONTINUUM CUP INSERTER BROKE OFF INTO CONTINUUM CUP. THE SURGERY WAS COMPLETED WITH NEW CUP AND INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536837 STRAIGHT SHELL INSERTER HIP INSTRUMENTS LXH ZIMMER BIOMET, INC. N/A 63192129

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention