BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC XR MP T1 PPS 9X102.5MM

    MDR report key: 23475094 · Received November 5, 2025

    Report

    Report Number
    0001825034-2025-03464
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304517288
    PMA / PMN Number
    K120030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. 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 RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH A VARUS ANGULATED PERIPROSTHETIC PROXIMAL FEMORAL FRACTURE AT THE TIP OF THE FEMORAL STEM. THE FRACTURE FIXATION HARDWARE SPANNING THE FRACTURE HAS FAILED PROXIMALLY AND THERE IS CALLUS FORMATION, BUT PERSISTENT LUCENCY, AT THE FRACTURE SITE SUSPICIOUS FOR NON-UNION. 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 FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. D10: CAT# 010000703 LOT# 7500022 G7 BONEMASTER LTD ACET SHL 52E. CAT# 11-363662 LOT# J7436980 36MM COCR MOD HD STD. CAT# 010000857 LOT# 7453710 G7 NEUTRAL E1 LINER 36MM E. G2: FOREIGN: AUSTRALIA. 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 AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY A YEAR AND A HALF LATER DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636288 TPRLC XR MP T1 PPS 9X102.5MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 7136719 00880304517288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.