BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 17808090 · Received September 25, 2023

    Report

    Report Number
    1818910-2023-19389
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    April 1, 2022
    Report Date
    September 25, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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 DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4-THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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

    ARTICLE ENTITLED ¿SURGICAL IMMOBILISATION DEVICES ARE USED IN CLINICAL STUDIES OF FULL HIP REPLACEMENT WITH DIRECT FORWARD ACCESS¿ WRITTEN BY DING XURU, SHAO JIAHUA, CAO JIA, CHEN YI, FU PEILIANG, AND WANG BO PUBLISHED IN JOURNAL OF THE NAVAL MILITARY MEDICAL UNIVERSITY IN APRIL OF 2023 WAS REVIEWED. THE PRIMARY AIM OF THIS STUDY WAS TO UNDERSTAND THE CLINICAL EFFICACY OF SURGICAL IMMOBILIZATION FOR DIRECT FRONT ACCESS FULL HIP REPLACEMENT AND ITS DIFFERENCE FROM CONVENTIONAL DIRECT FRONT ACCESS FULL HIP REPLACEMENT. 110 PATIENTS WERE INVOLVED IN THE STUDY. ALL WERE IMPLANTED WITH A PINNACLE CUP, NON-CEMENTED CORAIL OR TRILOCK, AND FEMORAL HEAD AND LINER. ADVERSE EVENTS: ONE PATIENT IN THE OBSERVATION GROUP HAD EXTRAFEMORAL THELIAL NEUROLOGIC INJURY AND TWO PATIENTS IN THE CONTROL GROUP EXTRAFEMORAL THELIAL NEUROLOGIC INJURY. ONE PATIENT IN THE CONTROL GROUP HAD POOR INCISIONAL HEALING AND HAD NORMAL HEALING AFTER CLEANING AND DRUG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241800 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention