BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 15710435 · Received November 1, 2022

    Report

    Report Number
    1038671-2022-01388
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    March 9, 2020
    Report Date
    May 21, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-2118-2021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. CONCOMITANTS: 164-12-11 - NOVATION ELEMENT RO X/O SZ 11, 2987162; 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, 2933850; 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2, 3605121. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT'S CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A FEMALE PATIENT, INITIAL LEFT HIP IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 5 YEARS 6 MONTHS POST THE INITIAL IMPLANT PROCEDURE AS OVER THE ENSUING YEARS, THE PLAINTIFF BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH EXCESSIVE WEAR OF THE GXL, INCLUDING PAIN AND LACK OF MOBILITY. THE REVISION SURGERY WAS NECESSARY DUE TO A FAILURE OF PLAINTIFF¿S GXL LINER. THE LINER WAS REPLACED. NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593083 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1