BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18084772 · Received November 7, 2023

    Report

    Report Number
    1038671-2023-02705
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    March 5, 2018
    Report Date
    April 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4952804 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM. 4887831 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3. 5067895 188-01-08 - WEDGE PLASMA X/O SZ 8. PENDING INVESTIGATION: 2 DEVICE SNS ARE PROVIDED VIA AN INVOICE, IT IS NOT KNOWN WHICH DEVICE WAS IMPLANTED: A. SN: (B)(6) ; 130-36-53 - NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS- MFG DATE 6 OCT 2017 & EXP DATE: (B)(6) 2022 B. SN: (B)(6); 130-36-53 - NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS- MFG DATE 2 JAN 2018 & EXP DATE: (B)(6) 2023.

    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.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2018. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. 2022 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469086 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. UNK 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10