BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 22575562 · Received July 23, 2025

    Report

    Report Number
    1038671-2025-02574
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    January 25, 2013
    Report Date
    September 2, 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: 142-36-00 - COCR FEM HEAD 36MM +0 OFFSET 12/14: 1188717, 160-70-15 - NV CEMENTED PLUS STD SIZE 15: 1431924, PC-17 - STEM CENTRALIZER 17MM: 0928534, 652-00-10 - OPTECURE WITH CCC - 10CC: 1462612. NON-EXACTECH CONCOMITANTS: 6202-58-20 - POROUS TRABECULAR METAL MODULAR, 6624-65-35 - SCREW, 6624-65-35 - SCREW, 6250-65-20 - SCREW, 6250-65-20 - SCREW, 6250-65-30 - SCREW, 00-4894-050-10 - ACETABULAR AUGMENT, 6310-58-36 - LONGEVITY CROSSLINKED LINER, 6250-65-25 - SCREW, 6250-65-25 - SCREW, 6704-0-410 - CABLE & SLEEVE SET, 6704-0-410 - CABLE & SLEEVE SET. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A HIP CLINICAL STUDY APPROXIMATELY 41 MONTHS AFTER A LEFT TOTAL HIP ARTHROPLASTY THE PATIENT EXPERIENCED DISLOCATION OF THE LEFT HIP. IT WAS REPORTED BY THE PATIENT THAT SEVERAL FAILED REDUCTION ATTEMPTS BY ANOTHER PHYSICIAN WERE ATTEMPTED AND THE DISLOCATION NEVER RESOLVED. AN ASPIRATION PROCEDURE BY ANOTHER PHYSICIAN WAS REPORTED THAT INDICATED BETA STREP FROM OTHER SOURCES. THE PATIENT ALSO REPORTED A HISTORY OF SEPSIS TO THE KIDNEYS AND GI TRACT WITH ERYTHEMA ABOUT THE LEFT HIP. THE PATIENT WAS INDICATED FOR EXPLANT OF SURGICAL HIP DEVICES WITH NO REVISION. THE PATIENT'S OUTCOME WAS REPORTED AS RESOLVED WITH THE EXPLANT OF SURGICAL HIP DEVICES. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870012 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| H SEE H11.