BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 9666285 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00024
    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
    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(TABLE 1 OF THE ATTACHED ARTICLE): THIS (B)(6) PATIENT WITH A BMI OF 19.18 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE -9.9 MM. AT 12 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 4 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, IMPLANT DATE, (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. THIS (B)(6) PATIENT WITH A BMI OF 19.18 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE -9.9 MM. AT 12 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 4 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
    128427 EXACTECH NOVATION GXL JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention