BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL CONSTRUCT CORAIL

    MDR report key: 21959268 · Received May 5, 2025

    Report

    Report Number
    1818910-2025-06999
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    November 9, 2024
    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). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, 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. H11 ADDITIONAL NARRATIVE: D2A. COMMON DEVICE NAME: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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: LIU X, GAO Y, LENG Y, ZHOU J, QI X. CLINICAL AND RADIOGRAPHIC OUTCOMES OF A LONG CEMENTLESS MONOBLOC STEM FOR REVISION TOTAL HIP ARTHROPLASTY DUE TO CHRONIC PERIPROSTHETIC INFECTION. J ARTHROPLASTY. 2025 MAY;40(5):1335-1339. DOI: 10.1016/J.ARTH.2024.11.007. EPUB 2024 NOV 9. PMID: 39528166. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO INVESTIGATE THE USE OF THIS STEM FOR 2-STAGE REVISION DUE TO CHRONIC PJI, ASSESSING THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF THIS PROSTHESIS OVER A MINIMUM 1-YEAR FOLLOW-UP PERIOD. THE INITIAL COHORT ENROLLED A SERIES OF 44 ADULTS (44 HIPS) WHO UNDERWENT 2-STAGE REVISIONS DUE TO CHRONIC PJI FROM JANUARY 1, 2017 TO MAY 5, 2022 AT THE MEDICAL CENTERS AND HAD A MEAN AGE OF 56 YEARS (RANGE, 24 TO 83) AND A MEAN BODY MASS INDEX OF 25.8 (RANGE, 17.3 TO 34.6).THE STUDY EVALUATED THE CORAIL REVISION STEMS IN A 2-STAGE EXCHANGE FOR PJI ( PERIPROSTHETIC JOINT INFECTION ). AN AVERAGE FOLLOW-UP OF 35.6 MONTHS (RANGE, 14 TO 75). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY CORAIL REVISION STEM. MANUFACTURER OF THE ACETABULAR CUP/LINER ARE NOT MENTIONED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY.28) (N=28) HAD POSITIVE MICROORGANISM CULTURES FROM THE HIP JOINT TISSUES OBTAINED DURING THE FIRST SURGERY; NO INTERVENTION WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832190 UNKNOWN HIP FEMORAL CONSTRUCT CORAIL PROSTHESIS, HIP, SEMI-CONSTRAINED LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention