BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT ATTUNE

    MDR report key: 22587597 · Received July 24, 2025

    Report

    Report Number
    1818910-2025-12786
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    September 20, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HO JPY, JAGOTA I, TWIGGS JG, LIU DWH. ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY RESULTS IN SHORTER NAVIGATION WORKING TIME WITH SIMILAR CLINICAL OUTCOMES COMPARED TO COMPUTER-NAVIGATED TOTAL KNEE ARTHROPLASTY. J ARTHROPLASTY. 2025 APR;40(4):893-899. DOI: 10.1016/J.ARTH.2024.09.026. EPUB 2024 SEP 20. PMID: 39307202. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE IF THERE IS A DIFFERENCE IN EARLY CLINICAL OUTCOMES, ESPECIALLY FUNCTIONAL OUTCOME MEASURES AND PROMS, BETWEEN PATIENTS WHO UNDERWENT TKA WITH CAS AND THOSE WHO UNDERWENT TKA WITH RAS. BETWEEN JANUARY 6, 2020 AND DECEMBER 19, 2022, A TOTAL OF 158 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 79 PATIENTS (40 MALE AND 39 FEMALE) WITH A MEAN AGE OF 68 ± 7.4 TOTAL KNEE ARTHROPLASTY WERE PERFORMED WITH CAS (BRAINLAB KNEE3 NAVIGATION, MUNICH, GERMANY) AND 79 PATIENTS (39 MALE AND 40 FEMALE) WITH A MEAN AGE OF 69 ± 7.4 TKAS WERE PERFORMED WITH RAS (VELYS ROBOTIC-ASSISTED SOLUTION (DEPUY SYNTHES, WARSAW, INDIANA). FULLY CEMENTED MOBILE-BEARING POSTERIOR STABILIZED PROSTHESES (ATTUNE, DEPUY SYNTHES, WARSAW, INDIANA) WERE IMPLANTED IN ALL CASES WITH PALACOS (HERAEUS, HANAU, GERMANY) BONE CEMENT, AND PATELLAE WERE RESURFACED ROUTINELY. FOLLOW-UP WERE UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES ATTUNE SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 2). -1 CASE OF PATELLAR CLUNK REQUIRING ARTHROSCOPIC DEBRIDEMENT. -1 CASE OF ACUTE PROSTHETIC JOINT INFECTION, WHICH WAS TREATED WITH DEBRIDEMENT. POLYETHYLENE EXCHANGE, AND IMPLANT RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221209 UNKNOWN KNEE CONSTRUCT ATTUNE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention