BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN HEAD

    MDR report key: 23880573 · Received December 23, 2025

    Report

    Report Number
    0001822565-2025-04780
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    July 6, 2025
    Report Date
    May 4, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D10: UNKNOWN HEAD, UNKNOWN LINER, UNKNOWN CUP, UNKNOWN STEM. G2: FOREIGN ¿ CHINA. G2: LITERATURE: XUE Z, GUO W, MU W, XU B, CAO L. TANTALUM VERSUS TITANIUM ACETABULAR COMPONENT IN SINGLE-STAGE HIP REVISION FOR PERIPROSTHETIC JOINT INFECTION: A COMPARATIVE ANALYSIS OF IMPLANT SURVIVORSHIP. J ORTHOP TRAUMATOL. 2025 JUL 23;26(1):49. DOI: 10.1186/S10195-025-00867-6. PMID: 40699476; PMCID: PMC12287478. THE CUSTOMER INDICATED THAT THE PRODUCT LOCATION IS UNKNOWN; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H6; H10. 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. 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 TRENDS.

    Description of Event or Problem · 0

    THE STUDY REPORTED THAT 2 PATIENTS WITHIN THE TA GROUP EXPERIENCED DISLOCATIONS WHICH WAS SUCCESSFULLY TREATED WITH CLOSED REDUCTION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Description of Event or Problem · 0

    DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616339 UNKNOWN HEAD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.