BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14239250 · Received April 28, 2022

    Report

    Report Number
    1038671-2022-00483
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 4, 2022
    Report Date
    August 9, 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

    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) THE PATIENT INVOLVED WAS REPORTED FOR REVISION DUE TO EARLY PROSTHESIS WEAR APPROXIMATELY 6 YEARS AFTER THE INDEX SURGERY. THE PROSTHESIS WEAR WAS ABLE TO BE CONFIRMED FROM THE PROVIDED RADIOGRAPH AND PHOTO OF THE EXPLANTED DEVICES; HOWEVER, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS 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 SIX YEARS POST INITIAL THA, THIS MALE PATIENT HAD A REVISION DUE TO WEAR OF NOVATION OF G2 36MM GXL LINER. PATIENT WAS REVISED TO NOVATION G2 36MM GXE INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HSS KEEPS ALL RETRIEVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142599 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 Male Required Intervention - ALTEON 6.5MM SCREW, 25MM.| - NV CROWN CUP CLSTR HOLE 52MM GROUP 2.| - WEDGE PLASMA X/O SZ 10.