BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 19425971 · Received May 30, 2024

    Report

    Report Number
    1818910-2024-11868
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    January 29, 2023
    Report Date
    May 30, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: REINBACHER P, HECKER A, FRIESENBICHLER J, SMOLLE M, LEITNER L, KLIM S, DRASCHL A, COLOVIC D, BRUNNADER K, LEITHNER A, MAURER-ERTL W. SIMULTANEOUS BILATERAL TOTAL HIP ARTHROPLASTY WITH STRAIGHT-STEMS AND SHORT-STEMS: DOES THE SHORT ONE DO A BETTER JOB? J CLIN MED. 2023 JAN 29;12(3):1028. DOI: 10.3390/JCM12031028. PMID: 36769676; PMCID: PMC9918178. H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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. 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: REINBACHER P, HECKER A, FRIESENBICHLER J, SMOLLE M, LEITNER L, KLIM S, DRASCHL A, COLOVIC D, BRUNNADER K, LEITHNER A, MAURER-ERTL W. SIMULTANEOUS BILATERAL TOTAL HIP ARTHROPLASTY WITH STRAIGHT-STEMS AND SHORT-STEMS: DOES THE SHORT ONE DO A BETTER JOB? J CLIN MED. 2023 JAN 29;12(3):1028. DOI: 10.3390/JCM12031028. PMID: 36769676; PMCID: PMC9918178. OBJECTIVE/METHODS/STUDY DATA: THE CURRENT STUDY AIMED TO COMPARE THE CLINICAL OUTCOME OF PATIENTS WITH UNILATERAL OR SIMULTANEOUS BILATERAL THA BY USING SHORT-STEM AND STRAIGHT-STEM DESIGNS AND FOCUSING ON OPERATION TIME, BLOOD LOSS, AND LENGTH OF HOSPITAL STAY (LOS). 92 PATIENTS WERE ENROLLED IN THE STUDY. 46 PATIENTS WERE IMPLANTED WITH SHORT STEMS WERE ALL COMPETITOR PRODUCTS. 46 PATIENTS WERE IMPLANTED WITH TRADITIONAL STEMS (CORAIL 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 CORAIL AND UNK HIP FEMORAL HEAD. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM CORAIL (QTY 10): 8 PATIENTS RECEIVED ALLOGENIC BLOOD PRODUCTS DUE TO LOW RBC COUNT AND SYMPTOMATIC SYMPTOMS. 1 REVISION DUE TO INCREASED SERUM METAL IONS CONCENTRATIONS AFTER THE USAGE OF A METAL-ON-METAL BEARING 57 MONTHS AFTER IMPLANTATION. 1 REVISION DUE TO JOINT INFECTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD (QTY 10): 8 PATIENTS RECEIVED ALLOGENIC BLOOD PRODUCTS DUE TO LOW RBC COUNT AND SYMPTOMATIC SYMPTOMS. 1 REVISION DUE TO INCREASED SERUM METAL IONS CONCENTRATIONS AFTER THE USAGE OF A METAL-ON-METAL BEARING 57 MONTHS AFTER IMPLANTATION. 1 REVISION DUE TO JOINT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285503 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention