BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 9666184 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00022
    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 THIS (B)(6) PATIENT WITH A BMI OF 25.96 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 11.3 MM. AT 26 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 2 OF 12 BEING REPORTED FOR PATIENTS. ALL CASES ARE CAPTURED AS THE FOLLOWING COMPLAINTS IN EXACTECH¿S GLOBAL COMPLAINT HANDLING SYSTEM: (B)(4).

    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 25.96 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 11.3 MM. AT 26 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 2 OF 12 BEING REPORTED FOR PATIENTS LISTED. 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
    130935 EXACTECH MCS GXL LINER JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention