BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL CONSTRUCT CORAIL

    MDR report key: 24586619 · Received March 12, 2026

    Report

    Report Number
    1818910-2026-04702
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    November 1, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 (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 MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D2A: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: THOEN PS, LINDALEN E, NORDSLETTEN L, RÖHRL SM. LOW WEAR WITH VITAMIN E-INFUSED HIGHLY CROSS-LINKED POLYETHYLENE : 14 YEARS' FOLLOW-UP OF A RANDOMIZED RADIOSTEREOMETRIC ANALYSIS STUDY. BONE JOINT J. 2025 NOV 1;107-B(11):1182-1188. DOI: 10.1302/0301-620X.107B11.BJJ-2025-0273.R1. PMID: 41173047. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE LONG- TERM POLYETHYLENE WEAR IN TOTAL HIP ARTHROPLASTY (THA) WITH 32 OR 36 MM CERAMIC HEADS ARTICULATING WITH A VEPE LINER. THIS STUDY IS A PROSPECTIVE RCT WITH NEARLY 14 YEARS OF FOLLOW- UP. 50 HIPS (49 PATIENTS AGED 50 TO 65 YEARS, 35 FEMALES) WERE OPERATED ON FROM JANUARY 2009 UNTIL FEBRUARY 2010. VEPE LINERS (E-POLY; ZIMMER BIOMET, USA) IN UNCEMENTED EXCEED ABT (ZIMMER BIOMET) SHELLS WITH 32 OR 36 MM BIOLOX DELTA CERAMIC HEADS (MANUFACTURED BY CERAMTEC FOR DEPUY, GERMANY) WERE USED. ALL PATIENTS RECEIVED AN UNCEMENTED CORAIL STEM (DEPUY). AFTER REAMING OF THE ACETABULUM, THE SCRUB NURSE SELECTED ONE OF TEN ENVELOPES RANDOMIZING THE PATIENT TO EITHER A 32 OR 36 MM FEMORAL HEAD. THE INCLUSION CRITERION WAS PRIMARY OSTEOARTHRITIS WITHOUT STRUCTURAL ABNORMALITY. TO DETECT A POLYETHYLENE WEAR DIFFERENCE OF 0.1 MM (SD 0.1) AND TO ACHIEVE A POWER OF 80% WITH = 0.05, WE CALCULATED THAT 17 PATIENTS HAD TO BE INCLUDED IN EACH GROUP. AT FINAL FOLLOW- UP, 32 PATIENTS (32 HIPS) WERE AVAILABLE FOR RADIOSTEREOMETRIC ANALYSIS (RSA). OVERALL, 17 PATIENTS HAD 32 MM HEADS, AND 15 PATIENTS HAD 36 MM HEADS. MEAN AGE AT FOLLOW-UP WAS 74 YEARS (66 TO 79). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY BIOLOX CERAMIC HEAD & CORAIL STEM. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: VEPE LINER (ZIMMER BIOMET). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY 7): (N=2) INFECTION; ONE PATIENT WAS OPERATED WITH SPACER. (N=1) PERIPROSTHETIC FRACTURE; FEMORAL HEAD CHANGED. (N=4) HETEROTOPIC BONE OSSIFICATION; NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647976 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