BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GXL NUETRAL LINER, G0 28MM ID

    MDR report key: 15988898 · Received December 15, 2022

    Report

    Report Number
    1038671-2022-01605
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    September 2, 2022
    Report Date
    April 16, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022059
    PMA / PMN Number
    K100269
    Removal / Correction Number
    Z-1731-2022
    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

    CONCOMITANT PRODUCTS: BIOLOX DELTA FEMORAL HEAD 28MM OD, -3.5MM (CAT# 170-28-93 / SERIAL# (B)(4)). CUP, CLUSTER-HOLE, 46MM GROUP 0 (CAT# 180-01-46 / SERIAL# (B)(4)). WEDGE PLASMA X/O SZ 1 (CAT# 188-01-01 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - BASED ON THE AVAILABLE INFORMATION, THE PATIENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS: SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER (DISLOCATION) 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 RISK FACTORS. HOWEVER, PROSTHESIS WEAR CANNOT BE CONFIRMED AS RADIOGRAPHS WERE NOT PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL BRIEF, ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY DUE TO SEVERE OSTEOARTHRITIS IN HER RIGHT HIP. ORTHOPEDIC SURGEON UTILIZED EXACTECH PRODUCTS IN PATIENT RIGHT HIP AND DID NOT BREACH ANY GENERALLY ACCEPTED STANDARD OF CARE IN THE FIELD OF ORTHOPEDIC SURGERY IN HIS CARE AND TREATMENT OF PATIENT NEGLIGENTLY CAUSE ANY INJURY TO HER. DURING THE SURGERY ON OR ABOUT NOVEMBER 28, 2018, PATIENT HAD AN EXACTECH NOVATION CROWN CUP SYSTEM IMPLANTED IN HER RIGHT HIP, WHICH INCLUDED THE FOLLOWING EXACTECH COMPONENTS (HEREINAFTER "THE DEVICE"): (1) 48 MM NOVATION CROWN CUP; (2) 28 MM NOVATION GXL LINER; (3) 28 MM BIOLOX DELTA FEMORAL HEAD; AND (4) SIZE 1 ALTEON TAPERED WEDGE FEMORAL STEM. AT THE TIME OF IMPLANT, EACH OF THE EXACTECH COMPONENTS OF PATIENT'S RIGHT HIP WAS IN SUBSTANTIALLY THE SAME CONDITION IN ALL RELEVANT RESPECTS AS WHEN THEY LEFT DEFENDANTS' CONTROL. ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT RIGHT HIP REVISION SURGERY DUE TO RIGHT TOTAL HIP DISLOCATION AND POLYETHYLENE WEAR. SURGEON NOTED IN THE REVISION OPERATIVE REPORT THAT "WITH THE HIP REDUCED ON FLUORO WITH A NON-WEIGHTBEARING FILM, YOU COULD STILL APPRECIATE A SLIGHT ECCENTRICITY OF THE FEMORAL HEAD WITHIN THE ACETABULAR LINER AND CUP, AND THIS IS SUSPICIOUS FOR POLYETHYLENE WEAR". PATIENT CONTINUES TO ENDURE PAINFUL RECOVERY AND REHABILITATION PROCESS FROM HER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205500 GXL NUETRAL LINER, G0 28MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. GXL NUETRAL LINER, G0 28MM ID UNK 10885862022059

    Patients

    Seq Age Sex Outcome Treatment
    1