BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STEM

    MDR report key: 24249010 · Received February 3, 2026

    Report

    Report Number
    0001822565-2026-00394
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    November 22, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A: IMPLANTED BETWEEN (B)(6) 2007 AND (B)(6) 2019. G2: FOREIGN - EVENT OCCURRED IN CHINA. G2: LITERATURE - XIAO, Q., CAO, J., XU, B., ET AL. (2025) RECONSTRUCTION OF PAPROSKY TYPE III ACETABULAR BONE DEFECTS IN REVISION HIP ARTHROPLASTY BY USING A COMBINATION OF CAGE AND MORSELIZED ALLOGRAFTS. BONE & JOINT, 6(11):1515-1522. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. 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 IN A JOURNAL ARTICLE THAT ONE PATIENT DEVELOPED SCIATIC NERVE PALSY POST HIP IMPLANTATION ON AN UNKNOWN DATE. THE PATIENT WAS MANAGED WITH NUTRITIONAL NERVE DRUGS AND REHABILITATION TRAINING AND RECOVERED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305430 UNK STEM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention