BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BIPOLAR VIVACIT-E

    MDR report key: 23014760 · Received September 10, 2025

    Report

    Report Number
    0001825034-2025-02861
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 18, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868418709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: JAPAN. G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT NUMBER 30123207 AND 510(K) K190660. 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. -VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTO FOUND THE PACKAGING WAS PREVIOUSLY OPENED. A HAIR-LIKE FIBER WAS FOUND IN THE STERILE PACKAGING/ON THE DEVICE. AS THE PRODUCT WAS RETURNED OPENED, THE SOURCE OF THE DEBRIS CANNOT BE CONFIRMED. -REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. -COMPLAINT IS NOT 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 WHEN THE IMPLANT WAS OPENED, A HAIR WAS FOUND INSIDE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS ABOUT A 3-MINUTE DELAY TO REPLACE THE PRODUCT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND 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
    1952488 RINGLOC BIPOLAR VIVACIT-E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67039986 00887868418709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown