BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MOD HD STD NECK TP1 TAPER

    MDR report key: 23867561 · Received December 22, 2025

    Report

    Report Number
    0001825034-2025-04150
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    March 2, 2023
    Report Date
    May 1, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    PMA / PMN Number
    K942479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: STRYKER LINER (COMPETITOR DEVICE), ITEM: 1236-2-848, LOT: 49335801. TAPERLOC POR FMRL 6.0X132, ITEM: 103201, LOT: 932200. M2A-MAGNUM PF CUP 48ODX42ID, ITEM: US157848, LOT: 226590. G2: FOREIGN ¿ CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO AN INTRAPROSTHETIC DISLOCATION. INTRAOPERATIVELY, DUAL MOBILITY COMPONENT WEAR, EFFUSION, AND MUSCLE DAMAGE WERE NOTED. COMPONENT EXCHANGE WITH THE STEM RETAINED WERE COMPLETED WITHOUT KNOWN COMPLICATIONS. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11149 28MM MOD HD STD NECK TP1 TAPER PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. 917770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H