BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM I.D. 42MM O.D. SIZE E BEARING

    MDR report key: 24740590 · Received March 31, 2026

    Report

    Report Number
    0001822565-2026-00991
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    December 26, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877502802 LOT# 3234114 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14V. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH LATER DUE TO A DISASSOCIATION BETWEEN THE BEARING AND HEAD OF A DUAL MOBILITY CONSTRUCT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799107 28MM I.D. 42MM O.D. SIZE E BEARING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67365832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.