BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    MDR report key: 19310042 · Received May 14, 2024

    Report

    Report Number
    1038671-2024-01230
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    November 22, 2023
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023421
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 1196947, 160-01-12 - PF STEM TAPERED PLASMA EXT OFFSET SZ 12, 1805391, 148-36-93 - 12/14 ZIRCONIA HEAD 36MM REP BY 170-36-93, 1921865, 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG, 1981842, 120-65-30 - BONE SCREW 6.5MM DIA X 30MM LONG ,2004745, 120-65-15 - BONE SCREW 6.5MM DIA X 15MM LONG, 2090596, 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG, 2098925, 180-01-56 - NV CROWN CUP CLSTR HOLE 56MM GROUP 3 2108346, 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THE PATIENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS: IMPLANTED WITH A LATERALIZED LINER, COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED, AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS MAY HAVE BEEN 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). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 148 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576178 NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862023421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.