BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL CONSTRUCT CORAIL

    MDR report key: 22371472 · Received July 1, 2025

    Report

    Report Number
    1818910-2025-10990
    Event Type
    Injury
    Date Received
    July 1, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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. H11 ADDITIONAL NARRATIVE: CORRECTED: H6 (HEALTH EFFECT - IMPACT CODE).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI J, ZHANG M, YAO J, SHAO L, FANG C, CHENG CK. RISK FACTORS FOR PERIPROSTHETIC FEMORAL FRACTURES AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY. J ARTHROPLASTY. 2024 OCT;39(10):2547-2554. DOI: 10.1016/J.ARTH.2024.06.005. EPUB 2024 JUN 6. PMID: 38851406. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE PRESENT STUDY AIMED TO IDENTIFY THE RISK FACTORS OF PERIPROSTHETIC FEMORAL FRACTURE AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY (THA) AND RANK THEM BASED ON IMPORTANCE. BETWEEN JANUARY 2012 AND DECEMBER 2019, A TOTAL OF 5459 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS. PERIPROSTHETIC FEMORAL FRACTURE (PFF) GROUP CONSISTED OF 111 PATIENTS (48 MALE AND 63 FEMALE) WITH A MEAN AGE OF 72.1±10.9 WHILE CONTROL GROUP CONSISTED OF 388 PATIENTS (184 MALE AND 204 FEMALE) WITH A MEAN AGE OF 62.4±11.7. THE FEMORAL STEMS USED IN THESE THAS WERE THE CORAIL (DEPUY, WARSAW, IN), PROFEMUR (NON - DEPUY PRODUCT), SYNERGY (NON-DEPUY PRODUCT), TAPERLOC (NON-DEPUY PRODUCT), OMNIFIT® (NON-DEPUY PRODUCT), AND EXCIA (NON-DEPUY PRODUCT). THE MEAN FOLLOW-UP TIME OF THE PATIENTS IN ALL REFERENCED STUDIES WAS AT LEAST 5 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES CORAIL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY 65). 36 PATIENTS HAD PERIPROSTHETIC FEMORAL FRACTURE. INTERVENTION WAS NOT MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429974 UNKNOWN HIP FEMORAL CONSTRUCT CORAIL HIP FEMORAL CONSTRUCT LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention