BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 22574590 · Received July 23, 2025

    Report

    Report Number
    1038671-2025-02572
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    December 19, 2010
    Report Date
    September 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    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: 180-01-56 - NV CROWN CUP CLSTR HOLE 56MM GROUP 3: 1915814, 122-65-35 - 6.5MM ACETABULAR BONE SCREW 35MM: 1910522, 122-65-30 - 6.5MM ACETABULAR BONE SCREW 30MM: 1653657, 138-36-53 - NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 3 CUP: 1762218, 142-36-93 - COCR FEM HEAD 36MM -3.5 OFFSET 12/14: 1646766, 160-71-15 - NV CEMENTED PLUS EXT SIZE 15: 1436857, PC-14 - STEM CENTRALIZER 14MM: 1362270. 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 INFORMATION. THE CAUSE OF THE PATIENT¿S DISLOCATION REPORTED IN THIS EVENT 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 RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. DISLOCATION AND SUBLUXATION ARE KNOWN RISKS, AS OUTLINED IN THE IFU. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 HIP STUDY APPROXIMATELY 15 YEARS AGO A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY 11 DAYS POST OP, THE PATIENT EXPERIENCED A DISLOCATION OF THE LEFT HIP AND UNDERWENT A CLOSED REDUCTION. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785406 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention SEE H11.