BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 9666480 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00030
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 1, 2020
    Report Date
    February 4, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION NOTED THIS (B)(6) YEAR-OLD PATIENT WITH A BMI OF 35.19 WAS IMPLANTED WITH A NOVATION/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 0 MM. AT 120 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE ACETABULUM LINER AND SECONDARY OSTEOLYSIS. ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER; NO ADDITIONAL INFORMATION WAS PROVIDED. WITHOUT ADDITIONAL INFORMATION, WE CANNOT REASONABLY DRAW A CONCLUSION AS TO THE CAUSE OF REVISIONS.

    Description of Event or Problem · 1

    WC T, HK P, RG V, CF G, EARLY POLYETHYLENE FAILURE IN A MODERN TOTAL HIP PROSTHESIS: A NOTE OF CAUTION, THE JOURNAL OF ARTHROPLASTY (2020), DOI: HTTPS://DOI.ORG/10.1016/J.ARTH.2019.12.043. THIS (B)(6) YEAR-OLD PATIENT WITH A BMI OF 35.19 WAS IMPLANTED WITH A NOVATION/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 0 MM. AT 120 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE ACETABULUM LINER AND SECONDARY OSTEOLYSIS. ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER; NO ADDITIONAL INFORMATION WAS PROVIDED. WITHOUT ADDITIONAL INFORMATION, WE CANNOT REASONABLY DRAW A CONCLUSION AS TO THE CAUSE OF REVISIONS. THIS IS PATIENT 10 OF 12 BEING REPORTED FOR PATIENTS LISTED IN TABLE 1 OF THE ARTICLE BEING SUBMITTED. ALL CASES ARE CAPTURED AS THE FOLLOWING COMPLAINTS IN EXACTECH¿S GLOBAL COMPLAINT HANDLING SYSTEM: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128445 EXACTECH NOVATION GXL LINER JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention