BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 9666315 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00025
    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 THAT AS REPORTED BY THE LITERATURE ARTICLE ¿EARLY POLYETHYLENE FAILURE IN A MODERN TOTAL HIP PROSTHESIS¿, THE EXACTECH NOVATION GXL LINER MAY BE PRONE TO A HIGH RATE OF EARLY FAILURE 26 FROM WEAR AND SEVERE SECONDARY OSTEOLYSIS. REVIEW OF OUR INSTITUTIONAL REGISTRY REVEALED A PREVALENCE OF SHORT TO MID-TERM FAILURES OF ONE SPECIFIC MODERN ACETABULAR POLYETHYLENE LINER COMPONENT, THE EXACTECH NOVATION GXL. 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. CASE RELATED TO PATIENT ID 5 (TABLE 1 OF THE ATTACHED ARTICLE): THIS (B)(6) YEAR-OLD PATIENT WITH A BMI OF 27.14 WAS IMPLANTED WITH A NOVATION/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE NOT AVAILABLE. AT 78 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. NO INFORMATION PROVIDED IN THE FOLLOWING (CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, AND EXPIRATION DATE).

    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. CASE RELATED TO PATIENT ID 5 (TABLE 1 OF THE ATTACHED ARTICLE): THIS (B)(6) YEAR-OLD PATIENT WITH A BMI OF 27.14 WAS IMPLANTED WITH A NOVATION/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE NOT AVAILABLE. AT 78 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 5 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: CASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129164 EXACTECH NOVATION GXL JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention