BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA STD NC SIZE 6

    MDR report key: 24313470 · Received February 11, 2026

    Report

    Report Number
    0001822565-2026-00465
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    February 4, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024508668
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. D10: CAT# 110010245 LOT# 66481744 G7 OSSEOTI 4 HOLE SHELL 54MM F. CAT# 00625006535 LOT# J7672880 BONE SCR 6.5X35 SELF-TAP. CAT# 30124006 LOT# 66760583 40MM I.D. SIZE F HIGH WALL LINER. CAT# 00877504002 LOT# 3201342 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 40/0, TAPER 12/14. 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 A TOTAL HIP REPLACEMENT AND SUSTAINED A FEMORAL FRACTURE APPROXIMATELY 1.5 MONTHS POST-IMPLANTATION. THE HEAD AND STEM WERE EXCHANGED WITH CERCLAGE WIRES TO FRACTURE AREA. THE SHELL AND LINER REMAINED IMPLANTED. NO OPERATIVE RECORDS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372779 AVENIR CMPL HA STD NC SIZE 6 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER BIOMET, INC. 3197305 00889024508668

    Patients

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