BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE EM TIBIAL DIST UPROD

    MDR report key: 23646788 · Received November 25, 2025

    Report

    Report Number
    1818910-2025-20741
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 17, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LXH
    UDI-DI
    10603295129752
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. TIBIA CUTTING GUIDE UPROD KNOB BECAME FULLY UNTHREADED AND WOULD NOT FULLY ENGAGE INTO CLAMP HOLDER. NO FURTHER INFO AVAILABLE." THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE ATTUNE EM TIBIAL DIST UPROD DID NOT HAVE ANY DEVICE ASSEMBLE TO IT, JUST SHOWS SIGNS OF MODERATE WEAR HOWEVER NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS OBSERVED. A FUNCTIONAL TEST WAS PERFORMED, AND THE ASSESSMENT FOUND THAT THE LEVER WAS ABLE TO WORK AS INTENDED, WITH NO DIFFICULTIES OBSERVED. ADDITIONALLY THE ATTUNE EM TIBIAL DIST UPROD WAS ABLE TO ASSEMBLED WITH ITS MATING DEVICE ATTUNE EM TIBIAL ANKLE CLAMP AND NO ISSUES WERE OBSERVED. 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 EM TIBIAL DIST UPROD 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 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: 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. 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 TIBIA CUTTING GUIDE UPROD KNOB BECAME FULLY UNTHREADED AND WOULD NOT FULLY ENGAGE INTO CLAMP HOLDER. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812543 ATTUNE EM TIBIAL DIST UPROD ATTUNE INSTRUMENTS : ALIGNMENT DEVICES LXH DEPUY IRELAND - 3015516266 PG306079 10603295129752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown