BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL®, ALPHA INSERT, HOODED, II/32

    MDR report key: 23468562 · Received November 4, 2025

    Report

    Report Number
    0009613350-2025-00853
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 9, 2025
    Report Date
    January 22, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024163010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. FITMORE®, SHELL WITH FINS, UNCEMENTED, 52/II ITEM# 0100024452 LOT# 3028067. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M,¸ 32/0, TAPER 12/14 ITEM# 00877503202 LOT# 3141133. UNKNOWN STEM ITEM# UNKNOWN LOT# UNKNOWN. G2. REPORT SOURCE: AUSTRALIA. 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 WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP REPLACEMENT, SUBSEQUENTLY, APPROXIMATELY 1 YEAR AND 8 MONTHS POST IMPLANTATION, UNDERWENT A REVISION DUE TO DISLOCATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589310 DURASUL®, ALPHA INSERT, HOODED, II/32 PROSTHESIS, HIP LZO ZIMMER GMBH 3166836 00889024163010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Hospitalization| R SEE H11 NARRATIVE.