BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR LINER POLY

    MDR report key: 18938260 · Received March 19, 2024

    Report

    Report Number
    1818910-2024-06113
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    June 5, 2023
    Report Date
    March 19, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    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). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THE SIZE OF THE ARTICLE IS TOO LARGE TO ATTACH/SUBMIT WITH THE 3500A SUBMISSION. THE CITATION OF THE ARTICLE HAS BEEN PROVIDED BELOW: ZHANG B, LI W, LI M, DING X, HUO J, WU T, HAN Y. THE ROLE OF 3-DIMENSIONAL PREOPERATIVE PLANNING FOR PRIMARY TOTAL HIP ARTHROPLASTY BASED ON ARTIFICIAL INTELLIGENCE TECHNOLOGY TO DIFFERENT SURGEONS: A RETROSPECTIVE COHORT STUDY. MEDICINE (BALTIMORE). 2023 JUN 23;102(25):E34113. DOI: 10.1097/MD.0000000000034113. PMID: 37352023; PMCID: PMC10289585. 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. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ZHANG B, LI W, LI M, DING X, HUO J, WU T, HAN Y. THE ROLE OF 3-DIMENSIONAL PREOPERATIVE PLANNING FOR PRIMARY TOTAL HIP ARTHROPLASTY BASED ON ARTIFICIAL INTELLIGENCE TECHNOLOGY TO DIFFERENT SURGEONS: A RETROSPECTIVE COHORT STUDY. MEDICINE (BALTIMORE). 2023 JUN 23;102(25):E34113. DOI: 10.1097/MD.0000000000034113. PMID: 37352023; PMCID: PMC10289585. OBJECTIVE AND METHODS: AUTHORS STUDIED THE IMPACT OF PREOPERATIVE PLANNING WITH COMPUTED TOMOGRAPHY (CT)-BASED 3-DIMENSIONAL (3D) TEMPLATING SOFTWARE FOR PRECISE PLACEMENT OF TOTAL HIP ARTHROPLASTY (THA) COMPONENTS. THEY INVESTIGATED THE ROLE OF A SOFTWARE PROVIDING 3-DIMENSIONAL PREOPERATIVE PLANNING FOR PRIMARY TOTAL HIP ARTHROPLASTY BASED ON ARTIFICIAL INTELLIGENCE TECHNOLOGY¿ARTIFICIAL INTELLIGENCE HIP (AIHIP)¿AND ITS IMPACT FOR SURGEONS WITH DIFFERENT EXPERIENCE LEVELS IN PRIMARY THA. IN THIS RETROSPECTIVE COHORT STUDY, PATIENTS WHO HAD UNDERGONE THA WITH THE HELP OF THE AIHIP, WERE MATCHED TO PATIENTS WHO HAD UNDERGONE THA WITHOUT THE HELP OF THE AIHIP, BY AGE AND THE DOCTOR WHO OPERATED ON THEM. THE SUBJECTS WERE DIVIDED INTO 4 GROUPS, SENIOR SURGEON (CHIEF OF SURGERY) WITH AIHIP GROUP, SENIOR SURGEON WITHOUT AIHIP GROUP, JUNIOR SURGEON (ASSOCIATE CHIEF OF SURGERY) WITH AIHIP GROUP AND JUNIOR SURGEON WITHOUT AIHIP GROUP. THE GENERAL DATA, IMAGING INDEX, CLINICAL OUTCOMES AND ACCURACY OF STEM SIZE PREDICTION AND CUP SIZE PREDICTION WERE RETROSPECTIVELY DOCUMENTED FOR ALL PATIENTS. A PINNACLE ACETABULAR CUP AND TRI-LOCK FEMORAL STEM WERE IMPLANTED IN ALL CASES, WITH CERAMIC HEADS ON POLYETHYLENE LINERS. THE AUTHORS DID NOT PROVIDE SPECIFIC PATIENT INFORMATION BY CASE NUMBER OR AGE/GENDER, NOR DID THEY IDENTIFY SPECIFIC PRODUCT CODE/LOT CODE DETAILS WITH REGARDS TO IMPLANTED DEVICES. RESULTS: THERE WAS A SIGNIFICANT DIFFERENCE IN DISCREPANCY IN LEG LENGTH, NECK-SHAFT ANGLE, AND FEMORAL OFFSET BETWEEN THE HEALTHY SIDE AND THE AFFECTED SIDE, OPERATION DURATION, DECREASE IN HEMOGLOBIN (HB) PER 24 HOURS, INTRAOPERATIVE RADIATION EXPOSURE FREQUENCY AND POSTOPERATIVE COMPLICATIONS AMONG THE PATIENTS IN JUNIOR SURGEON GROUP. NO SIGNIFICANT DIFFERENCES WERE FOUND BETWEEN SENIOR SURGEON GROUPS. THE STEM SIZES OF 95% WERE ACCURATELY ESTIMATED TO BE WITHIN 1 STEM SIZE, AND 97% OF THE CUP SIZE ESTIMATES WERE ACCURATE TO WITHIN 1 CUP SIZE IN SENIOR SURGEON GROUP WITH AIHIP. A TOTAL OF 87% STEM SIZES WERE ACCURATELY ESTIMATED TO BE WITHIN 1 STEM SIZE, AND 85% CUP SIZES WERE ACCURATE TO WITHIN 1 CUP SIZE IN JUNIOR SURGEON GROUP WITH AIHIP. IN CONCLUSION, OUR STUDY SUGGESTS THAT AN AI-BASED PREOPERATIVE 3D PLANNING SYSTEM FOR THA IS A VALUABLE ADJUNCTIVE TOOL FOR JUNIOR DOCTOR AND SHOULD ROUTINELY BE PERFORMED PREOPERATIVELY. COMPLICATIONS:__SENIOR SURGEON WITHOUT AIHIP_____SENIOR SURGEON WITH AIHIP PERIPROSTHETIC FRACTURE________2__________________________2 HIP DISLOCATION_______________2__________________________1 ASEPTIC LOOSENING___________0___________________________0 THIGH PAIN__________________4___________________________2 COMPLICATIONS:__JUNIOR SURGEON WITHOUT AIHIP_____JUNIOR SURGEON WITH AIHIP PERIPROSTHETIC FRACTURE_______8____________________________2 HIP DISLOCATION______________2____________________________3 ASEPTIC LOOSENING___________6____________________________0 THIGH PAIN__________________4____________________________5

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487151 UNK HIP ACETABULAR LINER POLY ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention