BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z1 HIP SYSTEM

    MDR report key: 24567356 · Received March 11, 2026

    Report

    Report Number
    0001822565-2026-00774
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    September 17, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K251906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877504002, LOT# 3243024, BIOLOX® DELTA, CERAMIC FEMORAL HEAD. CAT# 110010247, LOT# 67130424, G7 OSSEOTI 4 HOLE SHELL 58MM G . 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 THAT APPROXIMATELY TWO WEEKS POST RIGHT HIP IMPLANTATION, THE PATIENT WAS TREATED WITH ANTIBIOTICS DUE TO ERYTHEMA AND FIBROUS EXUDATE AT THE INCISION SITE. THERE WAS NO CONFIRMED INFECTION. A COURSE OF ANTIBIOTICS WAS GIVEN OUT OF CAUTION. ISSUE WAS RESOLVED AT THE NEXT FOLLOW UP APPROXIMATELY ONE MONTH LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632284 Z1 HIP SYSTEM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. ZB2500620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention