BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +5

    MDR report key: 20433523 · Received October 11, 2024

    Report

    Report Number
    1818910-2024-21462
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    October 7, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033448
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 (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.

    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 PART#136532320/ LOT#4233604 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 PART#136532320/ LOT#4233604 COMBINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE : LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314077 DELTA CER HEAD 12/14 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 4233604 10603295033448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention