BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR MULLER STEM 5 STANDARD

    MDR report key: 24007752 · Received January 8, 2026

    Report

    Report Number
    0009613350-2026-00009
    Event Type
    Injury
    Date Received
    January 8, 2026
    Report Date
    January 29, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024479531
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A. IMPLANTED DATE: UNKNOWN DATE IN 2021. D10. ALLOFIT ALLOCLAS SHELL 56/KK ITEM#: 4247, LOT#: 3058043. DURAL ALPHA INSERT NEUTR KK/32 ITEM#: 0100013411, LOT#: 3050069. SULOX¿¢, HEAD, M, ø 32/0, TAPER 12/14 ITEM#: 173206, LOT#: 3061339. G2: FOREIGN - EVENT OCCURRED IN GERMANY. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. ROOT CAUSE HAS BEEN IDENTIFIED AS THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ON AN UNKNOWN DATE IN 2021. SUBSEQUENTLY, THE PATIENT REQUIRED AN ADDITIONAL ARTHROSCOPIC PROCEDURE TO TREAT OSSIFICATIONS. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED THUS FAR. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69576 AVENIR MULLER STEM 5 STANDARD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER GMBH 3028611 00889024479531

    Patients

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