BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT NECK SEG 125D KLA

    MDR report key: 23745037 · Received December 8, 2025

    Report

    Report Number
    1818910-2025-21388
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    January 1, 2025
    Report Date
    December 8, 2025
    Manufacturer
    DEPUY IRELAND
    Product Code
    LXH
    UDI-DI
    10603295325178
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - CALCAR REAMER IS VERY DAMAGED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE CORAIL AMT NECK SEG 125D KLA HAD SIGNS OF EXTENSIVE AND REPEATED USE. ADDITIONALLY, THE COLOR DISC WAS MISSING. THE OBSERVED CONDITION APPEARS CONSISTENT WITH A RANDOM COMPONENT FAILURE, POTENTIALLY RESULTING FROM EXPOSURE TO UNINTENDED FORCES AND PROLONGED HEAVY USAGE, WHICH MAY HAVE CAUSED THE DISC TO FRACTURE OR FALL APART. HOWEVER, SINCE THE DISC WAS NOT RETURNED AND GIVEN THE LIMITED AVAILABLE INFORMATION AND THE LOW INCIDENCE OF THIS ISSUE, IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE. 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 CORAIL AMT NECK SEG 125D KLA WOULD HAVE CONTRIBUTED TO A 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. CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    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 AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CALCAR REAMER WAS VERY DAMAGED THE STATE OF THE PATIENT IS UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447840 CORAIL AMT NECK SEG 125D KLA FEMORAL TRIALS LXH DEPUY IRELAND SO2024914 10603295325178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CORAIL AMT NECK SEG 125D KLA| MODULAR CALCAR PLANER SML