BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT ATTUNE

    MDR report key: 23605484 · Received November 20, 2025

    Report

    Report Number
    1818910-2025-20413
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    July 21, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 MANUFACTURER NARRATIVE: D2A: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. 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. RECAPTURED CODES ON H6 (HEALTH EFFECT - CLINICAL CODE).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHERIDAN M, KRISHNAN P, FAROOQ H, GRAYSON W, REES H, BROWN N. LOW RATES OF EARLY ASEPTIC LOOSENING OF THE CEMENTED ATTUNE S+ TOTAL KNEE ARTHROPLASTY SYSTEM. CUREUS. 2025 JUL 21;17(7): E88406. DOI: 10.7759/CUREUS.88406. PMID: 40842796; PMCID: PMC12365711. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE RATE OF ASEPTIC LOOSENING WITH ATTUNE S+ IMPLANTS IN A SINGLE SURGEON¿S PRACTICE AT A TERTIARY CARE ACADEMIC MEDICAL CENTER. A TOTAL OF 47 PATIENTS WHO UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) WITH THE CEMENTED ATTUNE S+ SYSTEM BETWEEN NOVEMBER 2017 AND APRIL 2023 WERE IDENTIFIED. A MAJORITY OF THE PATIENTS (83%) WERE FEMALE, WITH AN OVERALL AVERAGE AGE OF 67 YEARS (RANGE = 42 TO 85 YEARS) AT THE TIME OF THE TKA. ALL PATIENTS UNDERWENT APPROPRIATE TIBIAL BASEPLATE SIZING AND WERE TAKEN THROUGH FULL RANGES OF MOTION TO ENSURE ADEQUATE SEATING. ALL BASEPLATES WERE CEMENTED WITH KNEES IN EXTENSION AND ADEQUATELY IRRIGATED. BOTH ATTUNE PS AND CR IMPLANTS WERE INCLUDED IN THIS STUDY. MEAN FOLLOW-UP PERIOD IS 21.6 MONTHS POST-SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES ATTUNE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 1): (N=1) ARTHROFIBROSIS; SUBSEQUENT OPERATION 27 MONTHS AFTER THE ORIGINAL TKA TO REMOVE SCAR TISSUE IN THE KNEE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309851 UNKNOWN KNEE CONSTRUCT ATTUNE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention