BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 22579746 · Received July 23, 2025

    Report

    Report Number
    1038671-2025-02583
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    August 3, 2012
    Report Date
    September 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 42-36-00 - COCR FEM HEAD 36MM +0 OFFSET 12/14: 2249249, 160-71-14 - NV CEMENTED PLUS STD, PC-15 - STEM CENTRALIZER 15MM: 1865243, 1217-22-052 - NON EXACTECH - POROCOAT SHELL, 1217-25-500 - NON EXACTECH -SCREW, 1217-35-500 - NON EXACTECH -SCREW, 1217-20-500 -NON EXACTECH -SCREW, 1219-36-152 - NON EXACTECH -ACETABULAR LINER. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, F. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S DISLOCATION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE TENSION, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. HOWEVER, THE FAILURE COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. DISLOCATION AND SUBLUXATION ARE KNOWN RISKS, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 157 MONTHS AGO. THE PATIENT EXPERIENCED A SECOND DISLOCATION APPROXIMATELY 2 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE AND 17 DAYS AFTER THE FIRST DISLOCATION. THE PATIENT UNDERWENT A SECOND CLOSED REDUCTION PROCEDURE. THE PATIENT'S OUTCOME WAS REPORTED AS RESOLVED WITH THE CLOSED REDUCTION PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000722 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention SEE H11.