BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV EHXL ALIP LNR G2 36MM

    MDR report key: 17808350 · Received September 25, 2023

    Report

    Report Number
    1038671-2023-02361
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    July 1, 2021
    Report Date
    December 7, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    OQI
    UDI-DI
    10885862537638
    PMA / PMN Number
    K173583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H 11. CORRECTION- THE DEVICE REPORTED IS NOT A RECALLED DEVICE-(B)(6) NV EHXL ALIP LNR G2 36MM-THERE ARE NO ISSUES REPORTED.

    Additional Manufacturer Narrative · 0

    B5. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4) CA 002670. THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE. D2B. HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEMENTED. D10. CONCOMITANTS: 180-65-45 -S040637 ALTEON 6.5MM SCREW, 45MM. 170-36-00 - 6878469 BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS REVISED TO A NOVATION GXL ON (B)(6) 2021. THE PATIENT HAS NOT BEEN REVISED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500732 NV EHXL ALIP LNR G2 36MM SEE H10 OQI EXACTECH, INC. 10885862537638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention