BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ATTUNE FEMORAL

    MDR report key: 20030420 · Received August 22, 2024

    Report

    Report Number
    1818910-2024-17772
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 21, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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

    SUBJECT ID:(B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR MIGRATION/LOOSENING, FEMORAL. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: (B)(6) 2024, DATE OF IMPLANT: INFORMATION NOT PROVIDED, DATE OF REVISION: INFORMATION NOT PROVIDED, DEVICE LOCATION: RIGHT, TREATMENT/IMPACT: INFORMATION NOT PROVIDED. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 151630608, LOT ID#: 3881469, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE CR/RP INSERT SZ 6 8MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117666 UNK ATTUNE FEMORAL KNEE FEMORAL IMPLANT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male ATTUNE CR RP INSRT SZ 6 8MM