BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 7X115

    MDR report key: 24997678 · Received April 27, 2026

    Report

    Report Number
    0001825034-2026-01070
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    September 22, 2010
    Report Date
    April 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K020580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-1042523 PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. D10: CAT# S001140 LOT# 830200 SELEX/MAGNUM MOD HD 40MM STD. CAT# US157846 LOT# 212290 M2A-MAGNUM PF CUP 46ODX40ID. G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. AFTER REMOVAL OF THE TRIAL FEMORAL COMPONENT, A GREATER TROCHANTERIC TIP FRACTURE WAS IDENTIFIED AND REPAIRED BY DRILLING WITH SOFT-TISSUE SUTURE FIXATION UTILIZING THE GLUTEUS MINIMUS. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544418 BI-METRIC/X POR NC 7X115 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET, INC. 067330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE