BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CR FEM TRIAL SZ 5 RT

    MDR report key: 23544183 · Received November 13, 2025

    Report

    Report Number
    1818910-2025-19744
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 29, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295133773
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED THAT THE POSTERIOR CONDYLE PART OF THE TRIAL BROKE OFF WHEN THE TRIAL WAS IMPACTED ONTO THE PATIENT'S FEMUR. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. (B)(4). THE PHOTO INVESTIGATION REVEALED THAT '254500705, ATTUNE CR FEM TRIAL SZ 5 RT HAS CONDYLE BROKEN. "THE FRACTURE SURFACE IS CONSISTENT WITH OVERLOAD DUE TO A COMBINATION OF HEAVY IMPACTION AND THE TRIAL FITTING TOO TIGHT OVER THE POSTERIOR/ANTERIOR ASPECT OF THE RESECTED FEMUR BONE FORCING THE CURVED FEATURES OF THE FEMORAL TRIAL TO OPEN. THE COMBINATION OF HEAVY IMPACTION AND POSSIBLE DISCREPANCIES IN THE RESECTION DEPTH BETWEEN THE FEMUR AND THE TRIAL SUGGEST UNINTENDED USER ERROR. FURTHERMORE, PER THE ATTUNE SURGICAL TECHNIQUE (DSUS/JRC/0316/1437 REV. K) IT IS CAUTIONED WHEN EXTRACTING THE TRIAL, ROCKING THE TRIAL MEDIO-LATERALLY MAY CAUSE CONDYLAR FRACTURE. SUCH ROCKING SHOULD BE AVOIDED." SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE CR FEM TRIAL SZ 5 RT WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE FEMORAL TRIAL HAS BROKEN BECAUSE OF UNINTENDED USER ERROR, AND 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 COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES 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: A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE LOT CODE PROVIDED IS NOT A VALID FINISHED GOODS LOT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 POSTERIOR CONDYLE PART OF THE TRIAL DEVICE BROKE OFF WHEN THE TRIAL WAS IMPACTED ONTO THE PATIENTS FEMUR. IT WAS REPORTED THAT ANOTHER SET WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED BY THREE MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120238 ATTUNE CR FEM TRIAL SZ 5 RT FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US (10)MVMKNH790 10603295133773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown