BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL AMT NECK SEG 135D KHO

    MDR report key: 21559191 · Received March 10, 2025

    Report

    Report Number
    1818910-2025-03665
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 10, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295325178
    PMA / PMN Number
    K142004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 135DEG HIGH OFFSET NECK TRIAL NOT CONNECTING TO TRIAL HEADS. REPLACEMENT REQUIRED. NO FRAGMENTS CREATED, 1MINUTE DELAY IN SURGERY. THE PRODUCT RETURNED TO MEDTECH ORTHOPAEDICS FOR EVALUATION. THE MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED THAT THE CORAIL AMT NECK SEG 135D KHO HAS THE CIRCLIPS RING DEFORMED. ADDITIONALLY, THE DEVICE EXHIBITS AN OVERALL WORN APPEARANCE CONSISTENT WITH NORMAL AND CONSTANT USAGE. A FUNCTIONAL TESTING WAS NOT PERFORMED AS THE MATING DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON THE OBSERVED CONDITION OF THE CIRCLIPS RING, IT IS REASONABLE THAT THE DEFORMATION CONTRIBUTES TO THE REPORTED ASSEMBLING ISSUES. THE OBSERVED CONDITION OF THE DEVICE APPEARS TO BE A RESULT FROM A COMBINATION OF HEAVY USE AND EXPOSURE TO UNINTENDED FORCES, SUCH AS PRYING MOTIONS APPLIED DURING REPEATED ASSEMBLY AND DISASSEMBLY CYCLES WITH THE MATING DEVICE. 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 135D KHO WOULD HAVE 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: ADDED: D9. 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 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: D4 (LOT), D9, H4. CORRECTED: D4 PRIMARY UDI NUMBER. 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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 135DEG HIGH OFFSET NECK TRIAL NOT CONNECTING TO TRIAL HEADS. REPLACEMENT REQUIRED. NO FRAGMENTS CREATED, 1MINUTE DELAY IN SURGERY. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT IMG_0472.JPEG. THE PHOTO INVESTIGATION REVEALED FOREIGN SUBSTANCE THAT APPEARS TO BE ORGANIC MATERIAL, CONSISTENT WITH NORMAL USE OF THE DEVICE IN A SURGICAL PROCEDURE. HOWEVER NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS OBSERVED. FUNCTIONALITY OF THE DEVICE CANNOT BE ASSESSED THROUGH PHOTO EVIDENCE PROVIDED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPH PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 135DEG HIGH OFFSET NECK TRIAL WAS NOT CONNECTING TO THE TRIAL HEADS. REPLACEMENT ARE REQUIRED. THERE WERE NO FRAGMENTS CREATED, 1MINUTE DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451996 CORAIL AMT NECK SEG 135D KHO FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US NB101902 10603295325178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male