BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS

    MDR report key: 19326143 · Received May 15, 2024

    Report

    Report Number
    1038671-2024-01281
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    October 4, 2022
    Report Date
    September 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024329
    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

    CONCOMITANT DEVICES: 2955949, 142-36-00 - COCR FEM HEAD 36MM +0 OFFSET 12/14 3713109 180-01-54 - NV CROWN CUP CLSTR HOLE 54MM GROUP 2 3728044 180-65-20 - ALTEON 6.5MM SCREW, 20MM 3747984 180-65-15 - ALTEON 6.5MM SCREW, 15MM 3816566 164-03-11 - ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 11 3874492 101-05-20 - 3.2MM DRILL BIT 20MM 1PK 3874493 101-05-20 - 3.2MM DRILL BIT 20MM 1PK 3933277 180-65-20 - ALTEON 6.5MM SCREW, 20MM. 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

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS AS SPECIFIED IN THE HHE: IMPLANTED WITH A LATERALIZED LINER AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REPORTED PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED MEDICAL DEVICE CLINICAL CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 89 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531401 NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024329

    Patients

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