BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 22413040 · Received July 7, 2025

    Report

    Report Number
    1818910-2025-11346
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: POLUS JS, KAPTEIN BL, VASARHELYI EM, LANTING BA, TEETER MG. EVALUATION OF CONVENTIONAL AND CT-BASED RADIOSTEREOMETRIC ANALYSIS FOR INDUCIBLE DISPLACEMENT MEASUREMENTS AFTER TOTAL HIP ARTHROPLASTY. J ORTHOP RES. 2025 JAN;43(1):192-199. DOI: 10.1002/JOR.25981. EPUB 2024 OCT 1. PMID: 39354712; PMCID: PMC11615423. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE USE OF COMPUTED TOMOGRAPHY-BASED RSA (CT-RSA) FOR ASSESSMENT OF IMPLANT STABILITY IN COMPARISON TO THE GOLD-STANDARD RSA. THIS IS A LEVEL 2 PROSPECTIVE COHORT STUDY WHERE PATIENTS (N = 79) WHO PREVIOUSLY PARTICIPATED IN A 2-YEAR PROSPECTIVE RSA STUDY WERE INVITED TO RETURN AT 5-YEARS POSTOPERATION TO BE RE-EXAMINED FOR IMPLANT STABILITY. PATIENTS UNDERWENT PRIMARY THA EITHER THE DIRECT LATERAL OR THE DIRECT ANTERIOR APPROACH DEPENDING ON THEIR SURGEON REFERRAL AND WERE RANDOMIZED TO RECEIVE EITHER A COLLARED OR COLLARLESS CORAIL CEMENTLESS FEMORAL STEM (DEPUY SYNTHES). AS REQUIRED FOR EACH PATIENT, THE SURGEON USED A STANDARD OR A HIGH-OFFSET STEM, ALONG WITH EITHER A 28, 32, OR 36 MM COBALT¿CHROMIUM FEMORAL HEAD. ALL PATIENTS RECEIVED A CEMENTLESS PINNACLE ACETABULAR CUP (DEPUY SYNTHES), WITH AN ALTRX HIGHLY CROSSLINKED ACETABULAR LINER (DEPUY SYNTHES) AS THE ACETABULAR COMPONENT. FINALLY, A TOTAL OF 48 PATIENTS (25 MALE AND 23 FEMALES; MEAN AGE OF 71.4 (50¿90) YEARS) WITH 5-YEAR FOLLOW-UP AND UNDERWENT BOTH RSA AND CT-RSA IMAGING WERE INCLUDED IN THE STUDY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES CORAIL STEM OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: DEPUY SYNTHES PINNACLE ACETABULAR COMPONENT ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM CORAIL (QTY 48): - THE MEAN ± STANDARD DEVIATION OF FEMORAL STEM SUBSIDENCE BETWEEN TWO AND 5 YEARS WAS 0.097 ± 0.197 MM. ALL PATIENTS EXPERIENCED LESS THAN 0.2 MM OF SUBSIDENCE/MIGRATION PER YEAR BETWEEN THE SECOND AND FIFTH YEARS OF FOLLOW-UP, INDICATING THEY ALL HAD WELL-FIXED, STABLE IMPLANTS (FIGURE 4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768206 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown