BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

    MDR report key: 17689308 · Received September 6, 2023

    Report

    Report Number
    1038671-2023-02160
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    September 21, 2020
    Report Date
    May 29, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862022165
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTEGRIP REV SHELL ACET DIA54MM PRESS FIT CLUS H GRP 2 (180-01-54, 3709792) STEM FEM OD9MM 12/14 COLLARED (164-03-09, 2544465) BIOLOX DELTA HEAD FEM OD32MM -3.5MM (170-32-93, 3810720) INVESTIGATION RESULTS- THE NV GXL LINR IS NOTED TO BE A RECALLED DEVICE. THE CAUSE OF THE PATIENT¿S CONDITION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. HETEROTOPIC OSSIFICATION IS THE PRESENCE OF BONE IN SOFT TISSUE. THERE IS NO MENTION OF DEVICE MALFUNCTION OR WEAR. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Description of Event or Problem · 0

    BRIEF POST-OP NOTE PATIENT WAS REVISED TO COMPETITOR'S FEMORAL HEAD AND COMPONENT. PROCEDURE-RIGHT HIP REVISION HIP STEM ANTERIOR APPROACH AND HETEROTOPIC OSSIFICATION EXCISION .PRE-OPERATIVE DIAGNOSIS: PRESENCE OF BOTH ARTIFICIAL HIP JOINTS. NO COMPLICATIONS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2015. THEY SUBSEQUENTLY UNDERWENT RIGHT HIP REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 5 YEARS 8 MONTHS POST PRIMARY PROCEDURE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056131 NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO EXACTECH, INC. UNK 10885862022165

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H10