BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CR FEM TRIAL SZ 6 RT

    MDR report key: 23268701 · Received October 10, 2025

    Report

    Report Number
    1818910-2025-17407
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 22, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> IT WAS REPORTED THAT THE LATERAL CONDYAL OF TRIAL BROKE OFF. THE PRODUCT RETURNED TO MEDTECH ORTHOPAEDICS FOR EVALUATION. THE MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED THAT ATTUNE CR FEM TRIAL SZ 6 RT HAS ONE CONDYLE BROKEN OFF; FRAGMENT WAS RETURNED FOR EVALUATION. 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. 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 CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE CR FEM TRIAL SZ 6 RT WOULD CONTRIBUTE 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 ==> THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.

    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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LATERAL CONDYAL OF TRIAL BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478550 ATTUNE CR FEM TRIAL SZ 6 RT FEMORAL TRIALS HWT DEPUY IRELAND - 9616671 MVMGYR120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown