BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19326162 · Received May 15, 2024

    Report

    Report Number
    1038671-2024-01282
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    February 20, 2024
    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: 4734090        170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM 4793775 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2 4845360 136-36-52 - NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS 4886116 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4887858 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2 4897301 190-30-06 - ALT HA S CLR STD SZ 6 4897570 190-30-07 - ALT HA S CLR STD SZ 7 4917254 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4923704 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4940750 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM 4941389 101-05-20 - 3.2MM DRILL BIT 20MM 1PK 4957702 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 79 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671141 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.