BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL

    MDR report key: 17607325 · Received August 23, 2023

    Report

    Report Number
    1038671-2023-02029
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    May 11, 2023
    Report Date
    September 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION- HEALTH EFFECT - CLINICAL CODE & MEDICAL DEVICE PROBLEM CODE D10. CONCOMITANTS: 120-65-30 - BONE SCREW 6.5MM DIA X 30MM LONG 2927658 142-36-93 - COCR FEM HEAD 36MM -3.5 OFFSET 12/14 2853191 164-11-11 - NOVATION ELEMENT RO S/O SZ 11 2883134 180-01-52 - NV CROWN CUP CLSTR HOLE 52MM GROUP 2 2881750. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B2: CORRECTED. H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN THE INCIDENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS: 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 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.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT-POSTOPERATIVE DIAGNOSIS: FAILURE OF RECALLED HARDWARE OF LEFT TOTAL HIP. PATIENT HAS POLYETHYLENE FAILURE WITH MARKED THINNING. "THIS IS PURE LATERAL WEAR." THE PATIENT WAS AWAKENED AND RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION. NO INTRAOPERATIVE COMPLICATIONS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT HIP REPLACEMENT SURGERY IN APPROXIMATELY 2014. THEY UNDERWENT REVISION IN (B)(6) 2023, APPROXIMATELY 9 YEARS 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
    1405315 NV GXL LINER NEUTRAL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO EXACTECH, INC. UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H SEE H10.| UNK.