BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL

    MDR report key: 22170858 · Received June 9, 2025

    Report

    Report Number
    0001825034-2025-01641
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 16, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304491854
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN ¿ JAPAN. THE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D9; G3; H2; H3; H6; H10 VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). FOR LOT 7193513 STERILITY HAS BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND A PACKAGING DESIGN ISSUE. THIS COMPLAINT IS CONFIRMED. 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 STERILE PACKAGING WAS FOUND DAMAGED WHILE INSPECTING STOCK. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654486 TAPERLOC COMPLETE PRIMARY FEMORAL PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 7193513 00880304491854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown