BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FEM NAR POR PS LT SZ 6

    MDR report key: 18977076 · Received March 26, 2024

    Report

    Report Number
    1818910-2024-06545
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 14, 2024
    Report Date
    March 25, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    MBH
    UDI-DI
    10603295041993
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 150411126/LOT 3931753 COMBINATION. 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 : A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 150411126/LOT 3931753 COMBINATION.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY. BONE WAS FRACTURED PRE OP WHICH WAS REASON FOR REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BILATERAL FRACTURES OF THE LATERAL FEMORAL CONDYLES. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558758 ATTUNE FEM NAR POR PS LT SZ 6 ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL MBH DEPUY IRELAND - 9616671 3931753 10603295041993

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention ATTUNE FB TIB BASE SZ 5 POR| ATTUNE FB TIB BASE SZ 5 POR| ATTUNE FEM NAR POR PS LT SZ 6| ATTUNE PS FB INSRT SZ 6 14MM| ATTUNE PS FB INSRT SZ 6 8MM