BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    MDR report key: 14269953 · Received May 3, 2022

    Report

    Report Number
    1038671-2022-00504
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    April 1, 2022
    Report Date
    August 4, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM (CAT# 170-36-00 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION. (H3) BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD IS CONFIRMED RADIOGRAPHICALLY AND ON THE PHOTOGRAPH OF THE ACETABULAR LINER, THE PATIENT IS NOTED TO HAVE UNDERGONE AN ANTERIOR APPROACH ON THE INDEX SURGERY, AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS). A RISK ASSESSMENT HAS BEEN INITIATED TO ESCALATE THIS ISSUE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL RIGHT THA, THIS 66 Y/O MALE PATIENT HAD A REVISION DUE TO SIGNIFICANT WEAR OF G2 36MM GXL NOVATION LINER. PATIENT WAS REVISED TO 36MM OPTION HEAD/+0 SLEEVE AND G2 36MM GXE NOVATION LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HSS KEEPS ALL RETRIEVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762745 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention - 6.5MM ACETABULAR BONE SCREW 25MM.| - ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 14.| - NV CROWN CUP CLSTR HOLE 52MM GROUP 2.