BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 19467486 · Received June 5, 2024

    Report

    Report Number
    1818910-2024-12318
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    December 31, 2023
    Report Date
    June 5, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI M, ZENG Y, NIE Y, LIAO K, PEI F, YANG J, XIE H, SHEN B. A HIGH RISK OF POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE IN DORR TYPE C FEMURS: A RETROSPECTIVE COHORT STUDY WITH 10-YEAR FOLLOW-UP DATA AND A PRELIMINARY MONOCHROMATIC IMAGE ANALYSIS. INT J SURG. 2024 JAN 1;110(1):296-305. DOI: 10.1097/JS9.0000000000000810. PMID: 37830949; PMCID: PMC10793812. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI M, ZENG Y, NIE Y, LIAO K, PEI F, YANG J, XIE H, SHEN B. A HIGH RISK OF POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE IN DORR TYPE C FEMURS: A RETROSPECTIVE COHORT STUDY WITH 10-YEAR FOLLOW-UP DATA AND A PRELIMINARY MONOCHROMATIC IMAGE ANALYSIS. INT J SURG. 2024 JAN 1;110(1):296-305. DOI: 10.1097/JS9.0000000000000810. PMID: 37830949; PMCID: PMC10793812. OBJECTIVE AND METHODS: THE AUTHORS USED COMPETITOR BRAND ABG II FEMORAL STEMS FOR TOTAL HIP ARTHROPLASTY IN SOME DORR TYPE C FEMURS AS EARLY ATTEMPTS. HERE, THE AUTHORS COMPARED THE LONG-TERM FOLLOW-UP RESULTS BETWEEN ABG II STEMS AND THE WELL-ESTABLISHED DEPUY CORAIL STEMS AND THEIR MONOCHROMATIC IMAGES. AUTHORS ENROLLED 43 SHORT ABG II STEMS AND 67 STANDARD-LENGTH CORAIL STEMS IMPLANTED IN DORR TYPE C FEMURS FOR THIS RETROSPECTIVE COHORT STUDY, WITH A MEAN FOLLOW-UP OF 10.3 YEARS. REVISION RATES, HARRIS HIP SCORES, AND RADIOLOGIC SIGNS WERE COMPARED. SPECTRAL CT SCANS FROM A REPRESENTATIVE SAMPLE WERE OBTAINED, AND MONOCHROMATIC IMAGES WERE RECONSTRUCTED. A QUANTITATIVE METHOD WAS DEVELOPED TO MEASURE THE VOLUME OF THE GAP AROUND STEMS. PATIENT-SPECIFIC FINITE ELEMENT ANALYSIS WAS CONDUCTED TO INVESTIGATE THE STRAINS. AUTHORS PROVIDED NO PRODUCT DETAILS ABOUT THE ACETABULAR SIDE CONSTRUCT¿MANUFACTURER(S) UNKNOWN. RESULTS: THE REVISION RATE OF COMPETITOR ABG II STEMS WAS SIGNIFICANTLY HIGHER THAN THAT OF DEPUY CORAIL STEMS (21% VS. 3%). IN THE MONOCHROMATIC IMAGES, THE ABG II GROUP HAD POORER OSSEOINTEGRATION MARKERS THAN THE DEPUY CORAIL GROUP. CONCLUSIONS: THERE WAS A HIGH RISK OF POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE FOR ABG II STEMS IN DORR TYPE C FEMURS. MONOCHROMATIC IMAGES PROVIDED SOME INSIGHT INTO THE FAILURE MECHANISM. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN CORAIL STEM, UNKNOWN FEMORAL HEAD. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CORAIL STEM (QTY 2) ONE PATIENT EXPERIENCED A PERIPROSTHETIC FEMUR FRACTURE, TREATED WITH REVISION SURGERY OF THE STEM AND HEAD. ONE PATIENT EXPERIENCED A PERIPROSTHETIC JOINT INFECTION, TREATED WITH REVISION SURGERY OF THE FEMORAL STEM AND HEAD. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK FEMORAL HEAD (QTY 2) ONE PATIENT EXPERIENCED A PERIPROSTHETIC FEMUR FRACTURE, TREATED WITH REVISION SURGERY OF THE STEM AND HEAD. ONE PATIENT EXPERIENCED A PERIPROSTHETIC JOINT INFECTION, TREATED WITH REVISION SURGERY OF THE FEMORAL STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296388 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention