BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16495859 · Received March 7, 2023

    Report

    Report Number
    1038671-2023-00383
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 16, 2023
    Report Date
    April 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE REVISION INVOLVED IN THE CASE MAY HAVE BEEN THE RESULT OF A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE INCLUDING BUT NOT LIMITED TO USE ERROR, IMPLANT POSITIONING, PATIENT FACTORS, AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE(S), RADIOGRAPHS, PHOTOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: INTEGRIP CC, CLUSTER 52MM, G2 (CAT# 186-01-52 / SERIAL#: (B)(4)), WEDGE PLASMA S/O SZ 2 (CAT# 188-00-02 / SERIAL# (B)(4)), BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM (CAT# 170-36-93 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL NOTIFICATION, AS A RESULT OF THE PREMATURE POLYETHYLENE FAILURE AND APPROXIMATELY 4 YEARS POST INITIAL THA, THE 67 Y/O MALE PATIENT IS SCHEDULED FOR A REVISION TOTAL HIP ARTHROPLASTY ON (B)(6) 2023. PATIENT HAS RETAINED LEGAL COUNSEL WITH RESPECT TO PRODUCT DEFECT CLAIMS ARISING FROM THE PREMATURE FAILURE OF HIS EXACTECH NOVATION TOTAL HIP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314960 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