BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY BONE SCREW SELF-TAPPING

    MDR report key: 22826709 · Received August 18, 2025

    Report

    Report Number
    0001822565-2025-02975
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    November 4, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119833
    PMA / PMN Number
    K934765
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT DATE ¿ UNKNOWN IN 2025. D10: CAT: PM0004069 LOT: 127540 ROCHA LEFT TRIFLANGE SZ 26, CAT: CP161951 LOT: 266680 TI LOCK-SCR CANCLS, CAT: CP161942 LOT: 259440 TI LOCK-SCR CANCLS, CAT: CP161943 LOT: 162350 TI LOCK-SCR CANCLS, CAT: CP161942 LOT: 610480 TI LOCK-SCR CANCLS, CAT: CP161945 LOT: 251480 TI LOCK-SCR CANCLS, CAT: CP161941 LOT: 170820 TI LOCK-SCR CANCLS, CAT: CP161951 LOT: 265550 TI LOCK-SCR CANCLS, CAT: CP161944 LOT: 780030 TI LOCK-SCR CANCLS, CAT: CP161941 LOT: 529910 TI LOCK-SCR CANCLS, CAT: CP161942 LOT: 653860 TI LOCK-SCR CANCLS. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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. 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 APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT WAS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134055 TRILOGY BONE SCREW SELF-TAPPING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. J6880245 00889024119833

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| H| O