BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CR FEM TRIAL SZ 7 RT

    MDR report key: 23134425 · Received September 24, 2025

    Report

    Report Number
    1818910-2025-16430
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 5, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY. CSSD IS COMPLAINING THE TRIAL TO BE FRACTURED. SEEN IN CSSD. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT FOUND SIGNS OF BREAKAGE, SIGNS OF USE WERE OBSERVED HOWEVER NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS OBSERVED. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE CR FEM TRIAL SZ 7 RT WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 5-31-2023. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO ANOMALIES NOTED. 4) EXPIRY DATE: N/A. 5) IFU REFERENCE: IFU-0902-60-046, REV B. DEVICE HISTORY REVIEW. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 5-31-2023. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO ANOMALIES NOTED. 4) EXPIRY DATE: N/A. 5) IFU REFERENCE: IFU-0902-60-046, REV B. CORRECTED: H3, H4.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRIAL WAS FRACTURED. SEEN IN CSSD. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430573 ATTUNE CR FEM TRIAL SZ 7 RT FEMORAL TRIALS HWT DEPUY IRELAND - 9616671 MVMJYK120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown