BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP ACETABULAR CUP PINNACLE

    MDR report key: 22041110 · Received May 17, 2025

    Report

    Report Number
    1818910-2025-08060
    Event Type
    Malfunction
    Date Received
    May 17, 2025
    Date of Event
    April 28, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H3, H6: 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CARDENAS JM, GORDON D, WADDELL BS, KITZIGER KJ, PETERS PC JR, GLADNICK BP. DOES ARTIFICIAL INTELLIGENCE OUTPERFORM HUMANS USING FLUOROSCOPIC-ASSISTED COMPUTER NAVIGATION FOR TOTAL HIP ARTHROPLASTY? ARTHROPLAST TODAY. 2024 MAY 27;27:101410. DOI: 10.1016/J.ARTD.2024.101410. PMID: 38840694; PMCID: PMC11150909. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE COMPARATIVE STUDY WAS DESIGNED, ASKING THE FOLLOWING RESEARCH QUESTIONS REGARDING FLUOROSCOPIC-ASSISTED COMPUTER NAVIGATION FOR THA: 1) IS AI MORE ACCURATE THAN HUMAN-CONTROLLED SOFTWARE FOR ASSESSING CUP INCLINATION AND ANTEVERSION? 2) IS AI MORE ACCURATE THAN HUMAN-CONTROLLED SOFTWARE FOR ASSESSING LLD? A TOTAL OF 420 PATIENTS WHO UNDERWENT UNILATERAL PRIMARY DA THA BY A SINGLE FELLOWSHIP-TRAINED ARTHROPLASTY SURGEON USING THE SAME IMPLANT SYSTEM (PINNACLE ACETABULAR COMPONENT AND ACTIS FEMORAL COMPONENT, DEPUY SYNTHES, WARSAW, IN) BETWEEN FEBRUARY 2022 AND AUGUST 2023. THE FIRST COHORT OF 211 PATIENTS [103 MALE AND 108 FEMALE; MEAN AGE OF 63 (RANGE 29-86) YEARS] REQUIRED INPUTS FROM A HUMAN TECHNICIAN (MANUAL), WHILE THE SECOND COHORT OF 209 PATIENTS [83 MALE AND 126 FEMALE; MEAN AGE OF 66 (RANGE 13-96) YEARS] USED AN AUTOMATED VERSION OF THE SOFTWARE CONTROLLED BY AI. ALL PATIENTS RECEIVED A STANDING AP RADIOGRAPH IN THE OFFICE AT THE 2-WEEK POSTOPERATIVE VISIT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PINNACLE ACETABULAR COMPONENT AND ACTIS FEMORAL COMPONENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 23): NINETY-FOUR PERCENT (199/211) OF CUPS IN THE MANUAL COHORT AND 95% (198/209) OF CUPS IN THE AI COHORT WERE IMPLANTED WITHIN THE LSZ AT POSTOPERATIVE EVALUATION- MEANING THAT 23 ACETABULAR CUPS TOTAL WERE OUTLIERS, HAVING BEEN MISPOSITIONED OUTSIDE OF THE LEWINNEK ¿SAFE-ZONE¿ (LSZ) TARGET INCLINATION AND ANTEVERSION OF 40 ± 10 AND 15 ± 10, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142887 UNK HIP ACETABULAR CUP PINNACLE HIP ACETABULAR CUP JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown