BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    MDR report key: 18910769 · Received March 15, 2024

    Report

    Report Number
    1038671-2024-00517
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    March 14, 2018
    Report Date
    October 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 162-00-03 - NECK PRESERVING STEM, STD OFFSET PLASMA SZ 3 2974736; 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM 4918625; 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3 4852829. THESE DEVICES ARE USED IN TREATMENT AND NOT IN DIAGNOSIS. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED:. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION IS A COMBINATION OF THE RISK FACTORS SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2018 APPROXIMATELY 6 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132513 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention