BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS

    MDR report key: 19182466 · Received April 25, 2024

    Report

    Report Number
    1038671-2024-00982
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    March 26, 2024
    Report Date
    July 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024336
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 3639235 164-02-09 - ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 9 3874494 101-05-20 - 3.2MM DRILL BIT 20MM 1PK 3887133 180-01-58 - NV CROWN CUP CLSTR HOLE 58MM GROUP 3 4008688 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4011815 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE IMPLANT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    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. H4: CORRECTED. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT (CONFIRMED ON X-RAY) PROCEDURE ON (B)(6) 2015 AND THEN WAS REVISED ON (B)(6) 2024. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR. THE STEM WAS RETAINED AND A NEW HEAD IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468279 NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention