BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS FEMORAL LT SZ 7 CEM

    MDR report key: 24052149 · Received January 13, 2026

    Report

    Report Number
    1818910-2026-00629
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    July 16, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042204
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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: H3, H6: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5, D10 (CONCOMITANT). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL EVENT INFORMATION WERE REVIEWED: COMPONENTS REMOVED: N/A. ATTUNE FEMORAL COMPONENT: YES, NO. ATTUNE FEMORAL STEM: YES, NO. ATTUNE TIBIAL BASE: YES, NO. ATTUNE TIBIAL INSERT: YES, NO.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ARTERITIS STADE 4 + INFECTION OF LEFT TKA, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 16 JUL 2025, DATE OF IMPLANT: ON (B)(6) 2022, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES; WAS THE SUBJECT READMITTED TO HOSPITAL: YES (READMISSION ON (B)(6) 2025); INJECTED MEDICATION: YES; ORAL MEDICATION: YES; COMPONENTS REMOVED (FEMORAL COMPONENT, FEMORAL STEM, TIBIAL INSERT, TIBIAL BASE). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440107, LOT NUMBER: JG6793, COMPONENT TYPE: FEMORAL COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED LEFT SIZE 7, CATALOG NUMBER: 150660005, LOT NUMBER: 3733875, COMPONENT TYPE: TIBIAL BASE COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION ROTATING PLATFORM TIBIAL BASE CEMENTED SIZE 5, CATALOG NUMBER: 151710706, LOT NUMBER: 9898466, COMPONENT TYPE: TIBIAL INSERT COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 7 6MM, CONCOMITANT PRODUCTS: CATALOG NUMBER: 66017750, LOT NUMBER: 61441115, COMPONENT TYPE: CEMENT, DESCRIPTION: NO INFORMATION PROVIDED.

    Description of Event or Problem · 0

    UPDATES RECEIVED: TREATMENT/IMPACT: OTHER - SPECIFY: TRANS-FEMORAL AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115657 ATTUNE CRS FEMORAL LT SZ 7 CEM KNEE FEMORAL JWH DEPUY IRELAND - 9616671 JG6793 10603295042204

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention ATTUNE CRS RP INSRT SZ 7 6MM| ATUNE REV RP TIB BASE SZ 5 CEM| COMPETITOR BONE CEMENT(66017750/61441115)| UNKNOWN KNEE FEMORAL STEM