BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP ACETABULAR CUP PINNACLE

    MDR report key: 19446652 · Received June 3, 2024

    Report

    Report Number
    1818910-2024-12050
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    December 12, 2022
    Report Date
    June 3, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT(B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEN X, LI S, WANG Y, LIU X, ZHANG Y, QIU G, QIAN W. ARTIFICIALLY INTELLIGENT THREE-DIMENSIONALLY-PRINTED PATIENT-SPECIFIC INSTRUMENT IMPROVES TOTAL HIP ARTHROPLASTY ACCURACY. J ARTHROPLASTY. 2023 OCT;38(10):2060-2067.E1. DOI: 10.1016/J.ARTH.2022.12.017. EPUB 2022 DEC 17. PMID: 36535443. 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: CHEN X, LI S, WANG Y, LIU X, ZHANG Y, QIU G, QIAN W. ARTIFICIALLY INTELLIGENT THREE-DIMENSIONALLY-PRINTED PATIENT-SPECIFIC INSTRUMENT IMPROVES TOTAL HIP ARTHROPLASTY ACCURACY. J ARTHROPLASTY. 2023 OCT;38(10):2060-2067.E1. DOI: 10.1016/J.ARTH.2022.12.017. EPUB 2022 DEC 17. PMID: 36535443. OBJECTIVE/METHODS/STUDY DATA: THIS CLINICAL STUDY AIMED TO DEVELOP A 3D-PRINTED ARTIFICIAL INTELLIGENT PSI TO GUIDE THE ACCURATE PLACEMENT OF ACETABULAR AND FEMORAL COMPONENTS WITH INCREASED PRODUCTION EFFICIENCY, VALIDATE THE ACCURACY AND CLINICAL OUTCOMES OF PSI VERSUS THE FREE-HAND TECHNIQUE, AND EVALUATE WHETHER THERE IS A LEARNING CURVE. 60 PATIENTS WERE INCLUDED WITHIN THE STUDY. 30 WITHIN THE PSI GROUP AND 30 WITHIN THE CONTROL/FREE HAND GROUP. ALL PATIENTS WERE IMPLANTED WITH PINNACLE CUPS AND EITHER CORAIL OR TRILOCK STEMS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK HIP FEMORAL STEM, UNK HIP ACETABULAR CUP PINNACLE, AND UNKNOWN HIP FEMORAL HEAD ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 1): CONTROL/CUP INCLINATION AND ANTEVERSION ERRORS THAN THE PIS GROUP (QTY 1). NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM (QTY 1): LLD DISCREPANCY WAS NOTED WITHIN THE CONTROL GROUP (QTY 1). NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD (QTY 1): LLD DISCREPANCY WAS NOTED WITHIN THE CONTROL GROUP (QTY 1). NO INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940803 UNK HIP ACETABULAR CUP PINNACLE HIP ACETABULAR CUP JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown