BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK VERSYS HEAD

    MDR report key: 23456771 · Received November 3, 2025

    Report

    Report Number
    0001822565-2025-03961
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    April 13, 2025
    Report Date
    November 18, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H6; H10 THE FOLLOWING SECTIONS WERE CORRECTED: H1 UNCHECK SUMMARY REPORT D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. - NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. - DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. - MEDICAL RECORDS WERE NOT PROVIDED. - A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. - 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.

    Additional Manufacturer Narrative · 0

    (B)(4). A2: AGE AT IMPLANT: BETWEEN 40 AND 64 YEARS. D6A: INITIAL PROCEDURES: BETWEEN MAR 2007 AND OCT 2013. D10: RSA BIOMEDICAL TANTALUM BEADS. G2: FOREIGN ¿ AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. CITATION: ROBERTSON, T.S., SOLOMON, L.B., HOWIE, D.W., ET AL. (2025). HIGHLY POROUS TANTALUM ACETABULAR COMPONENTS WITHOUT ANCILLARY SCREWS ARE NON-INFERIOR AT 7 YEARS WHEN COMPARED WITH TITANIUM COMPONENTS WITH ANCILLARY SCREW FIXATION: A RANDOMIZED CONTROL TRIAL. ARTHROPLASTY TODAY, 33(101709), 1-7. DOI: 10.1016/J.ARTD.2025.101709. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. 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 INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT WAS REVISED DUE TO INFECTION ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708862 UNK VERSYS HEAD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H