BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36MM I.D. SIZE II NEUTRAL LINER USE WITH 52MM O.D. SIZE II SHELL

    MDR report key: 15873253 · Received November 28, 2022

    Report

    Report Number
    0001822565-2022-03337
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    August 9, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K200823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT HAS BEEN PROVIDED AS THE COMPLAINT DESCRIPTION IN B5 UNDER MFR #0001822565-2022-03337 HAS BEEN UPDATED WITH ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT PROVIDED AS THE REP CLARIFIED THE SURGEON USED A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE AS ORIGINALLY REPORTED UNDER MFR # 0001822565 - 2022 - 03337 - 1 IN SECTION B5.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NICKS AND SCRATCHES FROM ATTEMPTED USE. NO OTHER DAMAGE WAS NOTED. 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 LINER COULD NOT ASSEMBLE MATING WITH THE CUP. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LINER COULD NOT ASSEMBLE WITH THE CUP. THERE WAS A FIVE MINUTE DELAY IN THIS SURGERY, AND THE SURGEON USED ANOTHER CERAMIC LINER TO FINISH THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LINER COULD NOT ASSEMBLE WITH THE CUP. THERE WAS A FIVE MINUTE DELAY IN THE SURGERY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER POLYETHYLENE LINER INSTEAD OF A CERAMIC LINER.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PREVIOUS COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514424 36MM I.D. SIZE II NEUTRAL LINER USE WITH 52MM O.D. SIZE II SHELL PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 64891808

    Patients

    Seq Age Sex Outcome Treatment
    1 Male