BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 8 CEM

    MDR report key: 24911905 · Received April 17, 2026

    Report

    Report Number
    1818910-2026-07060
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 1, 2026
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042426
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. PRODUCT DESCRIPTION: ATTUNE FB TIB BASE SZ 8 CEM. PRODUCT CODE: 150600008. LOT NUMBER: 7830037. DATE OF MANUFACTURING: 01-JAN-2014. EXPIRY DATE: 31-DEC-2023. QUANTITY TO BE MANUFACTURED: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: ATTUNE FB TIB BASE SZ 8 CEM, PRODUCT CODE: 150600008, LOT NUMBER: 7830037, AND ONE NON-CONFORMANCES WAS IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. 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: PRODUCT DESCRIPTION- ATTUNE FB TIB BASE SZ 8 CEM. PRODUCT CODE: 150600008. LOT NUMBER: 7830037. DATE OF MANUFACTURING: 01-JAN-2014. EXPIRY DATE: 31-DEC-2023. QUANTITY TO BE MANUFACTURED: (B)(4). ADDED: D1, D10 CONCOMITANT. CORRECTED: H4

    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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. TIBIAL IMPLANT WAS POSITIONED WITH A SLIGHT ANTERIOR SLOPE. TIBIA DEBONDED AT THE CEMENT/IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED. FEMUR WAS NOT LOOSE. NO DELAYS OR PT INJURY. DOI: (B)(6) 2014. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590711 ATTUNE FB TIB BASE SZ 8 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 7830037 10603295042426

    Patients

    Seq Age Sex Outcome Treatment
    1