BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR MULLER STEM 6 STANDARD

    MDR report key: 24831342 · Received April 9, 2026

    Report

    Report Number
    0009613350-2026-00207
    Event Type
    Injury
    Date Received
    April 9, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. SHELL POROUS WITH HOLES 52 MM O.D. ITEM# 00620005220 LOT# 61486663. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER ITEM# 00801802803 LOT# UNKNOWN. LINER 10 DEGREE ELEVATED RIM 28 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS ITEM# 00631005028 LOT# 6193043. UNKNOWN SCREW ITEM# UNKNOWN LOT# UNKNOWN (X3). G2: FOREIGN - EVENT OCCURRED IN SPAIN. 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 IS BEING CONSIDERED FOR A RIGHT HIP REVISION APPROXIMATELY 16 YEARS POST-IMPLANTATION DUE TO PAIN. THE PATIENT WAS NOTED TO HAVE AGE-RELATED BONE DETERIORATION. 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
    513657 AVENIR MULLER STEM 6 STANDARD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER GMBH 4012714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.