BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9/10 ULTAMET 36MM HEADS +3

    MDR report key: 20449563 · Received October 15, 2024

    Report

    Report Number
    1818910-2024-21533
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 30, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295330073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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: 962712000, LOT: 2920870 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: 962712000, LOT: 2920870 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA THA FOR OSTEOARTHRITIS OF THE HIP. AFTER THE SURGERY, UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. THE SURGEON COMMENTED THAT HE PRESUMED METALLOSIS DUE TO METAL ON METAL. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SURGEON BELIEVES THAT THE METALLOSIS WAS CAUSED DUE TO OSTEOLYSIS AND THE PSEUDO-TUMOR-LIKE SHADOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319506 9/10 ULTAMET 36MM HEADS +3 SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2920870 10603295330073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN HIP ACETABULAR LINERS.| UNKNOWN HIP FEMORAL HEAD.