BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 9666194 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00021
    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 40.85 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 5.60 MM. AT 40 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE ACETABULUM LINER AND SECONDARY OSTEOLYSIS. THIS IS PATIENT 1 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). TWELVE PATIENTS WERE IDENTIFIED WITH NINE UNDERGOING REVISION SURGERY. ALL PATIENTS DEMONSTRATED RADIOGRAPHIC OSTEOLYSIS AT THE TIME OF REVISION SURGERY. THE AVERAGE TIME TO DIAGNOSIS OF FAILURE WAS 55.9 MONTHS (RANGE 12 ¿ 120 MONTHS). AVERAGE CUP POSITION PRE-OPERATIVELY WAS 44 DEGREES INCLINATION (RANGE 36 ¿ 53 DEGREES) AND 21 DEGREES ANTEVERSION (RANGE 10 ¿ 34 DEGREES). NINE PATIENTS UNDERWENT REVISION OF THE ACETABULAR COMPONENT, WITH TWO ALSO UNDERGOING FEMORAL COMPONENT REVISION. 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. (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. CASE RELATED TO PATIENT ID 1(TABLE 1 OF THE ATTACHED ARTICLE): THIS (B)(6) PATIENT WITH A BMI OF 40.850000000000001 WAS IMPLANTED WITH A MCS/GXL ACETABULUM LINER. POST-OPERATIVE LEG DISCREPANCY WAS REPORTED TO BE 5.60 MM. AT 40 POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE ACETABULUM LINER AND SECONDARY OSTEOLYSIS. THIS IS PATIENT 1 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
    131277 EXACTECH MCS GXL LINER JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention