BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 16271172 · Received January 31, 2023

    Report

    Report Number
    1038671-2023-00083
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    June 9, 2022
    Report Date
    March 2, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, REASON NOT REPORTED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    CONCOMITTANTS: 4893075 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, 4852825 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2, 4367272 188-00-06 - WEDGE PLASMA S/O SZ 6. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 5 YEARS 5 MONTHS POST THE INITIAL PROCEDURE FOR REASONS UNKNOWN. THE PLAINTIFF HAS ENDURED AND CONTINUES TO ENDURE A PAINFUL RECOVERY AND REHABILITATION PROCESS FROM HIS REVISION SURGERY. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871612 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 Male Required Intervention SEE H10.