BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV CROWN CUP CLSTR HOLE 48MM GROUP 1

    MDR report key: 22859786 · Received August 21, 2025

    Report

    Report Number
    1038671-2025-02809
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862036995
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D6A, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, E, F THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OVER THE COURSE OF OVER 13 YEARS OF IMPLANTATION, PATIENT-RELATED CONSIDERATIONS, AND A COMBINATION OF RISK FACTORS: SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) INCLUDING IMPINGEMENT AND EDGE LOADING. ACETABULAR CUP LOOSENING MAY BE AN ADDITIONAL REASON FOR THE REPORTED REVISION, BUT THIS CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO RELEVANT CLINICAL NOTES WERE 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

    D10: 132-28-51 - NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS: (B)(6). 148-28-00 - 12/14 ZIRCONIA HEAD 28MM +0MM NECK: 2024038 MONOBLOCK STEM: S/N. H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2025-02808. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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 A PATIENT UNDERWENT A LEFT HIP TOTAL ARTHROPLASTY. SUBSEQUENTLY, THIRTEEN AND HALF (13.5) YEARS LATER, THE PATIENT'S X-RAYS INDICATED A MALPOSITIONED ACETABULAR CUP AND POLYETHYLENE WEAR. THE PATIENT UNDERWENT A LEFT HIP REVISION FOUR (4) DAYS LATER. THE ACETABULAR CUP, LINER AND FEMORAL HEAD WERE REVISED. THE CUP AND LINER WERE NOTED TO BE A COMPETITOR'S IMPLANTS. INTRAOPERATIVELY, IT WAS NOTED THE PATIENT NEEDED BONE GRAFT DUE TO POLY WEAR, OSTEOLYSIS AND CUP REMOVAL. THERE WAS AN UNEXPECTED SURGICAL DELAY OF 30-45 MINUTES REPORTED DUE TO THE ACETABULAR CUP BEING LOOSE AND FALLING OUT. AS A RESULT, A FULL ACETABULAR COMPONENT REVISION WAS NEEDED INSTEAD OF THE PLANNED REVISION OF JUST THE POLYETHYLENE COMPONENTS AND THE FEMORAL HEAD EXCHANGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973815 NV CROWN CUP CLSTR HOLE 48MM GROUP 1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862036995

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H SEE H11.