BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 5 CEM

    MDR report key: 23852122 · Received December 19, 2025

    Report

    Report Number
    1818910-2025-22279
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 4, 2025
    Manufacturer
    DEPUY IRELAND
    Product Code
    JWH
    UDI-DI
    10603295042396
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿LEFT KNEE REVISION FOR TIBIAL ASEPTIC LOOSENING AT THE IMPLANT/CEMENT INTERFACE. CEMENT NOT FROM DEPUY. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT DR. WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: KNEE PAIN - TIBIAL LOOSENING., DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2025, REASON FOR REVISION SURGERY. KNEE PAIN - TIBIAL LOOSENING., PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? KNEE PAIN., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF -->NONE, IP-02599334 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE¿. PRODUCT DESCRIPTION:- ATTUNE FB TIB BASE SZ 5 CEM PRODUCT CODE:- 150600005 LOT NO:- 8220541 QUANTITY OF MANUFACTURED:- 12 DATE OF MANUFACTURING:- 11/27/2025 EXPIRY DATE:- 10/31/2025 IFU REFERENCE:- 090200828 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION:- ATTUNE FB TIB BASE SZ 5 CEM PRODUCT CODE:- 150600005 LOT NO:- 8220541 AND TWO NON-CONFORMANCES WERE 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 ==> 1) QUANTITY MANUFACTURED: 12 2) DATE OF MANUFACTURE: 11/27/2025 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: TWO NON-CONFORMANCES WERE IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. 4) EXPIRY DATE: 10/31/2025 5) IFU REFERENCE: 090200828 DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: - ATTUNE FB TIB BASE SZ 5 CEM PRODUCT CODE:- 150600005 LOT NO:- 8220541 AND TWO NON-CONFORMANCES WERE IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. ADDED: D10 ( CONCOMITANT )

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR PAIN AND TIBIAL ASEPTIC LOOSENING AT THE IMPLANT/CEMENT INTERFACE. CEMENT NOT FROM DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259955 ATTUNE FB TIB BASE SZ 5 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND 8220541 10603295042396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention