BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 9666281 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00023
    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 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 1: THIS (B)(6) PATIENT WITH A BMI OF 22.43 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 5.60 MM. AT 81 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE ACETABULUM LINER AND SECONDARY OSTEOLYSIS. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER; NO ADDITIONAL INFORMATION WAS PROVIDED. CONSIDERING THIS INFORMATION IS MULTIFACTORIAL AND SPECIFIC INFORMATION COULD NOT BE REVIEWED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION OF THE CAUSE. THIS IS PATIENT 3 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). NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): SEX, WEIGHT, ETHNICITY, RELEVANT TESTS/LABORATORY DATA, CATALOG NUMBER (CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, AND EXPIRATION DATE), IMPLANT DATE, EXPLANT DATE, DATE RECEIVED BY MANUFACTURER, DEVICE MANUFACTURE 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 1(TABLE 1 OF THE ATTACHED ARTICLE): THIS (B)(6) PATIENT WITH A BMI OF 22.43 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 5.60 MM. AT 81 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE ACETABULUM LINER AND SECONDARY OSTEOLYSIS. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER; NO ADDITIONAL INFORMATION WAS PROVIDED. CONSIDERING THIS INFORMATION IS MULTIFACTORIAL AND SPECIFIC INFORMATION COULD NOT BE REVIEWED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION OF THE CAUSE. THIS IS PATIENT 3 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
    128076 EXACTECH NOVATION GXL JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention