BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE FEMORAL

    MDR report key: 22589600 · Received July 24, 2025

    Report

    Report Number
    1818910-2025-12844
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    February 1, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG H, CHANG X, YU F, ZHANG M, LIU Y, MAN J, GUO K, MENG H, ZHANG W. INFLUENCING FACTORS OF THE OUTCOME OF PATIENTS WITH HAEMOPHILIA AFTER KNEE REPLACEMENT-A RETROSPECTIVE STUDY. BMC MUSCULOSKELET DISORD. 2025 FEB 1;26(1):102. DOI: 10.1186/S12891-025-08354-Z. PMID: 39893362; PMCID: PMC11786560. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVE OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE THE FACTORS INFLUENCING KNEE REPLACEMENT SURGERY RESULTS IN HEMOPHILIC PATIENTS. A TOTAL OF 87 PATIENTS WITH HEMOPHILIA (PWH) (117 KNEES) WHO UNDERWENT KNEE ARTHROPLASTY FROM JANUARY 2012 TO DECEMBER 2020 WERE INCLUDED IN THE STUDY. BONE TRANSPLANTATION WAS EMPLOYED TO FIX BONE DEFECTS USING CEMENT AND METAL SPACES, DEPENDING ON THE SIZE OF THE DEFECT. ALL CASES RECEIVED A CEMENTED POSTERIOR-STABILIZED (PS) KNEE PROSTHESIS. ALL KNEES RECEIVED JOHNSON & JOHNSON¿S PROSTHESIS (ATTUNE TOTAL KNEE SYSTEM). THE FOLLOW-UP RANGED FROM 47 TO 120 MONTHS (MEAN FOLLOW-UP 70.8±22 MONTHS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES ATTUNE TOTAL KNEE SYSTEM. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: BONE CEMENT (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 43): (N=20) BLEEDING AND HEMARTHROSIS KNEES, INCLUDING 5 CASES IN THE EXCELLENT GROUP AND 15 CASES IN THE POOR GROUP. 16 KNEES WERE TREATED WITH INCREASED AMOUNTS OF COAGULATION FACTOR CONCENTRATE (5 KNEES IN THE EXCELLENT GROUP; 11 KNEES IN THE POOR GROUP), AND 4 WERE TREATED WITH INCISION AND DRAINAGE OF THE HEMATOMA. (N=18) 2 KNEES IN THE EXCELLENT GROUP AND 16 IN THE POOR GROUP HAD STIFFNESS AND REQUIRED MANIPULATION UNDER ANESTHESIA (P <0.001), OF THESE, 2 KNEES IN EXCELLENT GROUP UNDERWENT MANUAL RELEASE ONLY UNDER ANESTHESIA, WHILE 11 KNEES REQUIRED ARTHROSCOPIC RELEASE AND 5 KNEES UNDERWENT MANUAL RELEASE ONLY UNDER ANESTHESIA IN POOR GROUP. (N=2) WOUND NECROSIS REQUIRING WOUND REVISION. (N=1) PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR IN THE POOR GROUP AT 5.4 YEARS, WHICH WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. (N=2) KNEES WITH PERIPROSTHETIC JOINT INFECTION WERE TREATED WITH TWO-STAGE REVISION TKA IN THE POOR GROUP AT 4.2 YEARS AND 4.8 YEARS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE FEMORAL (QTY 2): (N=2) FEMORAL COMPONENT LOOSENING IN THE POOR GROUP AT 4.3 YEARS AND 6.1 YEARS, WHICH REQUIRED REVISION TKAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371190 UNK ATTUNE FEMORAL KNEE FEMORAL IMPLANT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention