BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STEM TRIAL

    MDR report key: 23643388 · Received November 25, 2025

    Report

    Report Number
    1818910-2025-20697
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H11 ADDITIONAL NARRATIVE: ADDED: B5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ATTUNE REVISION BOSS REAMER AND UNK STEM TRIAL WERE INVOLVED IN AN EVENT. DURING PREPARATION FOR A FEMORAL IMPLANT, A 14X50MM STEM EXTENSION DISENGAGED FROM THE ATTUNE BOSS FEMORAL REAMER AND WAS NOT NOTICED TO BE MISSING WHEN THE REAMER WAS REMOVED FROM THE BONE. THE SURGICAL TEAM PROCEEDED WITH REAMING AND IMPLANT PLACEMENT, AND THE STEM EXTENSION WAS LATER DISCOVERED ON POST-OPERATIVE X-RAYS TO BE RETAINED IN THE PATIENT'S FEMORAL DIAPHYSIS ABOVE THE FINAL PLACEMENT OF THE FEMORAL COMPONENT. THE RETAINED STEM EXTENSION DID NOT RESTRICT THE PLACEMENT OF THE 60MM PRESS FIT STEM, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS. THE STATUS OF THE UNK STEM TRIAL IS THAT IT REMAINS IN THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE ALLEGATION IS THE ATTUNE REVISION CEMENTED STEM TRIAL 14MM X 50MM (ITEM# 2512-40-050) DISENGAGED FROM THE ATTUNE REVISION BOSS REAMER (ITEM # 2504-40-551), WHEN IT WAS BEING USED TO PREPARE THE DISTAL METAPHYSIS FOR THE BOSS OF THE ATTUNE REVISION CRS FEMUR IMPLANT. THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE AND ONLY USED THE REAMER IN THE FORWARD DIRECTION. AT SOME POINT DURING THE REAMING THE ATTUNE REVISION CEMENTED STEM TRIAL (ITEM# 14MM X 50MM), UNTHREAD FROM THE ATTUNE REVISION BOSS REAMER (ITEM# 2504-40-551), AND WAS LEFT IN THE PATIENT'S FEMORAL DIAPHYSIS, WITHOUT BEING CAUGHT BY THE STAFF IN THE OPERATING, THE DOCTOR, AND MYSELF. IT WAS DISCOVERED AT TIME OF POST OPERATIVE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790467 UNK STEM TRIAL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY ORTHOPAEDICS INC US 251240050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention