BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 24561141 · Received March 10, 2026

    Report

    Report Number
    1818910-2026-04528
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 19, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWR
    UDI-DI
    10603295148425
    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: ACCORDING TO THE INFORMATION RECEIVED, ¿THE TIP OF THE INSTRUMENT BROKE DURING SURGERY. THE HOSPITAL HAS EXPERIENCED THIS ISSUE WITH THIS INSTRUMENT BEFORE (SEE ATTACHED PHOTO). THIS OCCURRED DURING THE OPERATION; THE BROKEN FRAGMENT ENTERED THE PATIENT AND IS SOMETIMES DIFFICULT TO LOCATE AND REMOVE. THIS MAY POSE RISKS TO THE PATIENT.¿ THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT SCHERMAFBEELDING 2026-02-26 153042.PNG. REVIEW OF THE PHOTOGRAPHIC EVIDENCE REVEALED THE SHAFT WITHOUT THE TIP, INDICATIVE OF BREAKAGE. HOWEVER, THE TIP WAS NOT OBSERVED IN THE PROVIDED PICTURE. THE FRACTURE IS CONSISTENT WITH CYCLIC BENDING LOADING OF THE INSERTER TIP THAT EXCEEDED THE FATIGUE STRENGTH OF THE MATERIAL. PREVIOUS INVESTIGATIONS BASED ON FAILURE ANALYSIS THROUGH COMPLAINT DATA, IDENTIFIED THAT EXPOSURE TO HIGH-CYCLE IMPACT LOADING, PARTICULARLY WHEN COMBINED WITH SLIGHTLY OFF-CENTER AND/OR IRREGULAR IMPACT PATTERNS, CAN INDUCE CYCLIC BENDING STRESSES ON THE INSERTER TIP. THESE CONDITIONS MAY SIGNIFICANTLY ACCELERATE THE PROPAGATION OF FATIGUE CRACKS, ULTIMATELY LEADING TO THE MECHANICAL FAILURE OF THE IMPACTOR TIP. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. 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 CONFIRMED AS THE OBSERVED CONDITION OF THE COR/TRI ANT STEM INSERT SHAFT 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 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. ADDED: D9.

    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: CORRECTED: H6 - REMOVED PATIENT CODE: FOREIGN BODY AND PEC: FUNCTIONAL - FOREIGN BODY LEFT IN PATIENT. 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). 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.

    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: B5. 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 TIP OF THE INSTRUMENT BROKE DURING SURGERY. THE BROKEN FRAGMENT ENTERED THE PATIENT AND WAS DIFFICULT TO LOCATE AND REMOVE. THIS MAY POSE RISKS TO THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE BROKEN FRAGMENT HAS NOT BEEN LEFT IN THE PATIENT. THE HOSPITAL IS NO LONGER USING THE INSTRUMENT AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136492 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENTS : INSERTION DEVICES HWR DEPUY ORTHOPAEDICS INC US PG342870 10603295148425

    Patients

    Seq Age Sex Outcome Treatment
    1