BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSYS LNR AOX N 50X36

    MDR report key: 20913958 · Received December 12, 2024

    Report

    Report Number
    1818910-2024-25281
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 27, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    UDI-DI
    10603295501244
    PMA / PMN Number
    K221636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S PRIMARY HIP WAS REVISED DUE TO INFECTION. DURING THIS HEAD AND POLY SWAP PROCEDURE, THE PATIENT'S PRIMARY FEMORAL HEAD AND POLYETHYLENE LINER WERE REMOVED. HIP WAS THOROUGHLY WASHED OUT. A REPLACEMENT ACETABULAR LINER AND FEMORAL HEAD WERE THEN IMPLANTED. THE PATIENT'S HIP WAS REDUCED AND CLOSED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THERE WAS NO PATIENT HARM/CONSEQUENCE RELATED TO OUR IMPLANTS, BUT HER HIP WAS INFECTED BECAUSE OF HER INITIAL SURGICAL PROCEDURE. ALSO, THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146127 EMSYS LNR AOX N 50X36 HIP IMPLANT : ACETABULAR LINER LPH DEPUY IRELAND - 9616671 4566503 10603295501244

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention