BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRX NEUT 36IDX56OD

    MDR report key: 17764239 · Received September 18, 2023

    Report

    Report Number
    1818910-2023-18818
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 18, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016342
    PMA / PMN Number
    K072963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED, FOR THE FINISHED DEVICE PRODUCT CODE:122136056, LOT#: 4110215. AND NO NON-CONFORMANCES/MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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 MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED, FOR THE FINISHED DEVICE PRODUCT CODE:122136056, LOT#: 4110215. AND NO NON-CONFORMANCES/ MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LINER WOULD NOT SEAT FLUSH WITHIN THE CUP. REMOVED AND REPLACED WITH DIFFERENT LINER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268078 ALTRX NEUT 36IDX56OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 4110215 10603295016342

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male UNKNOWN HIP ACETABULAR CUP