BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMSYS LNR AOX N 50X36

    MDR report key: 20713672 · Received November 18, 2024

    Report

    Report Number
    1818910-2024-24029
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    November 6, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295501244
    PMA / PMN Number
    K221636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 RECORDS EVALUATION (MRE) WAS NOT PERFORMED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H11 ADDITIONAL NARRATIVE: ADDED: B5, D6A, D6B, D10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT (RIGHT SIDE) ON (B)(6) 2024. THE CERAMIC HEAD WOULD NOT SEAT INTO THE LINER. SURGEON SEEMS TO THINK THAT THE DIAMETER OF THE LINER WAS TOO SMALL. THEY HAD TO PULL THE LINER OUT OPEN A NEW ONE AND IMPLANT IT AGAIN. THIS WAS NOTICED DURING FINAL X-RAYS. PROCEDURE WAS COMPLETED WITH AN UNKNOWN SURGICAL DELAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCES DUE TO REPORTED EVENT? JUST LONGER OR TIME AND GETTING OUT THE POLY IN GENERAL. B. WAS THERE ANY SURGICAL DELAY RELATED TO EVENT? YES, SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987694 EMSYS LNR AOX N 50X36 HIP IMPLANT : ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US 4582695 10603295501244

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female DELTA CER HEAD 12/14 36MM +1.5