BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-MAX S STEM

    MDR report key: 24911465 · Received April 17, 2026

    Report

    Report Number
    3008021110-2026-00190
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    February 9, 2023
    Report Date
    April 13, 2026
    Product Code
    KWY
    UDI-DI
    08033390298926
    PMA / PMN Number
    K160011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF DHRS OF LOT NUMBER 2213329 DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALIES. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    THE COMPLAINT SOURCE REPORTED THAT DURING A HIP SURGERY AN INTRAOPERATIVE PERIPROSTHETIC FRACTURE OCCURRED THAT REQUIRED OSTEOSYNTHESIS WITH CERCLAGE WIRES. THE OUTCOME OF THE SURGERY WAS SATISFACTORY: AFTER ONE YEAR NO SIGN OF DISLOCATION/LOOSENING/FRACTURE. FRACTURE HEALED WITHOUT ANY FURTHER COMPLICATIONS IN FEW MONTHS. PATIENT IS WITHOUT SYMPTOMS AND WALKS WITHOUT ANY AIDS. THE IMPLANTED DEVICES DURING THE PROCEDURE ARE: H-MAX S STANDARD FEM.STEM #13 (PRODUCT CODE: 4250.20.130, LOT: 2213329 - STER: (B)(4)). FEM. MODULAR HEAD - L Ø28MM (PRODUCT CODE: 5010.09.283, LOT: 2223627 - STER: (B)(4)) . LOCK BIPOL.SELF-CENT.HEAD Ø52 (PRODUCT CODE: 5527.09.520, LOT: 2118970 - STER: (B)(4)). THE COMPLAINT WAS RECEIVED BY OUR CLINICAL DEPARTMENT AS AN SAE REPORTED AS PART OF A CLINICAL STUDY. THE EVENT WAS ASSESSED BY THE HOSPITAL'S CLINICAL STUDY TEAM AND WAS CONSIDERED NOT RELATED TO THE MEDICAL DEVICE, BUT TO THE SURGICAL PROCEDURE. THE FRACTURE WAS MOST LIKELY RELATED TO THE LIMITED EXPERIENCE OF THE SURGEON IN TRAINING WITH UNCEMENTED STEMS IN THE ELDERLY POPULATION. THE EVENT OCCURRED IN SLOVENIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967167 H-MAX S STEM H-MAX S STEM - STANDARD - TAPER 12/14 #13 H.155MM KWY 4250.20.130 2213329 08033390298926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention