BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL CONSTRUCT CORAIL

    MDR report key: 24560402 · Received March 10, 2026

    Report

    Report Number
    1818910-2026-04514
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    September 25, 2025
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES HAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D10 (CONCOMITANT). 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: YONGJIAN L, HAO L, FU J, ZHANG G, HAO L, CHAI W, NIU E, CHEN J. FOURTH-GENERATION CERAMIC-ON-CERAMIC THA WITH ANATOMIC AND TAPERED FEMORAL STEMS: 11-YEAR FOLLOW-UP. ORTHOP SURG. 2025 DEC;17(12):3373-3384. DOI: 10.1111/OS.70188. EPUB 2025 NOV 7. PMID: 41203236; PMCID: PMC12685480. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO ASSESS THE DIFFERENCE IN THE 11- YEAR FOLLOW- UP SURVIVAL RATES OF CERAMIC- ON- CERAMIC (COC) TOTAL HIP ARTHROPLASTY (THA) BETWEEN TAPERED STEMS AND AN ATOMICAL STEMS AND THE DIFFERENCE IN THE CLINICAL OUTCOMES BETWEEN THE TAPERED STEMS AND ANATOMICAL STEMS. BETWEEN JANUARY 2009 AND DECEMBER 2011, A TOTAL OF 591 HIPS WITH CORAIL STEM AND A TOTAL OF 334 HIPS WITH RIBBED STEMS (THE AGE IN THE CORAIL COHORT WAS 67.7 ± 13.5 YEARS AND THE AGE IN THE RIBBED COHORT WAS 69.4 ± 13.0 YEARS) ALL PATIENTS UNDERWENT TOTAL HIP ARTHROPLASTY. EACH PATIENT RECEIVED A CEMENTLESS HIP PROSTHESIS, EQUIPPED WITH A BIOLOX DELTA COC BEARING (MANUFACTURED BY CERAMTEC, GERMANY). THE ACETABULAR COMPONENTS, WHICH WERE ALSO CEMENTLESS (BETACUP, LINK, GERMANY), WERE IMPLANTED USING THE PRESS- FIT TECHNIQUE, WITHOUT THE USE OF ANY ADDITIONAL SCREWS. FOR THE FEMORAL COM PONENTS, EITHER RIBBED OR CORAIL, THE FEMORAL MEDULLARY CAVITY WAS FIRST REAMED, FOLLOWED BY THE PRESS- FIT IMPLANTATION OF THE COMPONENTS. THE MEAN FOLLOW UP FOR CORAIL COHORT (114.3 ± 9.6) AND RIBBED COHORT (118 ± 9.7) OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: BIOLOX DELTA COC BEARING (MANUFACTURED BY CERAMTEC, GERMANY), CEMENTLESS (BETACUP, LINK, GERMANY) LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CORAIL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY 14) N=5; PERIPROSTHETIC FRACTURES - NO INTERVENTION REPORTED. N=2; PERIPROSTHETIC JOINT INFECTIONS - NO INTERVENTION REPORTED. N=7; HETEROTOPIC OSSIFICATION - NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108070 UNKNOWN HIP FEMORAL CONSTRUCT CORAIL FEMORAL CONSTRUCT CORAIL LZO DEPUY FRANCE SAS - 3003895575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BIOLOX DELTA COC BEARING| CEMENTLESS BETACUP