BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    MDR report key: 17229536 · Received June 29, 2023

    Report

    Report Number
    1038671-2023-01507
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    December 20, 2018
    Report Date
    May 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION- B5. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 3712029 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2 4896707 190-31-07 - ALT HA S CLR EXT SZ 7 4931245 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM.

    Description of Event or Problem · 0

    PREOPERATIVE DIAGNOSIS: LOOSE RIGHT TOTAL HIP. THE HEAD BALL WAS TAKEN OFF ANT THE STEM WAS "WIGGLING" AND THAT THE CALCAR WAS RIGHT ON THE COLLAR OF THE STEM. THE CUP WAS WELL FIXED. NEW DEVICES WERE TRAILED AND IMPLANTED. THE PATIENT WAS TAKEN TO PACU IN STABLE FASHION WITH SUCCESSFUL RIGHT HIP REVISION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REPLACEMENT ON (B)(6) 2017. THEY SUBSEQUENTLY HAD RIGHT HIP REVISION ON (B)(6) 2018, APPROXIMATELY 1 YEAR 3 MONTHS AFTER THEIR INITIAL 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
    1476416 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention