BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CHARNLEY

    MDR report key: 19193101 · Received April 26, 2024

    Report

    Report Number
    1818910-2024-09242
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    May 27, 2023
    Report Date
    April 26, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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 WHITE-GIBSON A, SHERIDAN GA, GHETTI AC, KEOGH P, KENNY P, CASHMAN JP. THE UTILITY OF CEMENTED FEMORAL STEMS IN MODERN THA: A 10-YEAR COMPARATIVE ANALYSIS OF THE CHARNLEY AND EXETER STEMS. IR J MED SCI. 2024 FEB;193(1):251-255. DOI: 10.1007/S11845-023-03381-Y. EPUB 2023 MAY 27. PMID: 37243843; PMCID: PMC10810030. OBJECTIVE AND METHODS: THE PRIMARY AIM OF THIS STUDY IS TO ASSESS THE 10-YEAR OUTCOMES OF CEMENTED STEMS COMPARING 956 CHARNLEY AND 395 COMPETITOR STEMS REVISED BETWEEN JANUARY 2005 AND JUNE 2008 WITH PROSPECTIVELY COLLECTED DATA FROM THE IRISH NATIONAL JOINT REGISTRY. THE SECONDARY AIM WAS TO ASSESS THE MAIN PREDICTORS OF REVISION WITH THESE TWO COMMON CEMENTED FEMORAL STEMS. THE AUTHORS NOTE THAT MOST PATIENTS HAD METAL ON POLYETHYLENE ARTICULATIONS. THE MANUFACTURER OF FEMORAL HEAD AND ACETABULAR LINER ASSOCIATED WITH THE CHARNLEY STEM IS NOT SPECIFIED BUT ASSUMED TO BE DEPUY. THE AUTHORS DO NOT PROVIDE THE MANUFACTURER OF THE CEMENT UTILIZED WITH THE STEMS. THIS COMPLAINT WILL CAPTURE THE RESULTS ASSOCIATED WITH THE DEPUY CHARNLEY CONSTRUCT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CHARNLEY FEMORAL STEM, UNKNOWN METAL FEMORAL HEAD, UNKNOWN POLY ACETABULAR LINER ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: 6 REVISIONS FOR INFECTION, 3 REVISIONS FOR INSTABILITY/DISLOCATION, 2 REVISIONS FOR ASEPTIC LOOSENING OF THE STEM AT AN UNKNOWN INTERFACE, 2 REVISIONS FOR UNSPECIFIED ¿OTHER¿ REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045664 UNK HIP FEMORAL STEM CHARNLEY FEMORAL STEM LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention