BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z1 OFFSET STEM INSERTER

    MDR report key: 21535290 · Received March 6, 2025

    Report

    Report Number
    0001822565-2025-00545
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    January 31, 2025
    Report Date
    June 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00887868577888
    PMA / PMN Number
    K233476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;D4;D10;G3;H2;H3;H6. D10: CAT# 574201010 LOT# 3212859 AVENIR CMPL HA STD COL SIZE 1. DEVICE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE TIP OF THE INSERTER WAS FRACTURED OFF. THE TIP WAS NOT RETURNED. THE DEVICE SHOWED SIGNS OF USE. THERE WERE SOME SCRATCHES ON THE SHAFT, AND THERE WERE MARKS ON THE STRIKE PLATE. ALL DIMENSIONS CHECKED WERE FOUND TO BE CONFORMING. AN ANALYSIS OF THE INSERTER DETERMINED A BENDING OVERLOAD FAILURE MODE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY, AND IT WAS DETERMINED THAT THE FOLLOWING IMPLANTS/INSTRUMENTS ARE NOT COMPATIBLE: THE Z1 INSERTER USED WITH THE AVENIR STEM. MEDICAL RECORDS WERE NOT PROVIDED. THE COMPLAINT WAS CONFIRMED BASED ON THE RETURNED, FRACTURED DEVICE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE INSERTER HANDLE WAS BROKEN. THE INSERTER WAS USED DURING THE INSERTION OF THE STEM; HOWEVER, THE BREAK WAS NOT NOTICED UNTIL AFTER THE CASE DURING REASSEMBLING OF THE TRAYS AFTER WASHING THE DEVICE. THERE IS NO INFORMATION ON THE LOCATION OF THE FRACTURED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535477 Z1 OFFSET STEM INSERTER HIPS, INSTRUMENTS LZO ZIMMER BIOMET, INC. N/A 104095 00887868577888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown