BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH, INC.

    MDR report key: 9666616 · Received February 4, 2020

    Report

    Report Number
    1038671-2020-00032
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION NOTED 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. AS REPORTED BY THE LITERATURE ARTICLE ¿EARLY POLYETHYLENE FAILURE IN A MODERN TOTAL HIP PROSTHESIS¿, THE EXACTECH CONNEXION GXL LINER MAY BE PRONE TO A HIGH RATE OF EARLY FAILURE 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 CONNEXION GXL. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ARTICLE AUTHORS, HOWEVER; THEY REPLIED THAT NO ADDITIONAL INFORMATION WILL BE MADE AVAILABLE. CONSIDERING THIS INFORMATION IS MULTIFACTORIAL AND SPECIFIC INFORMATION COULD NOT BE REVIEWED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION AS TO THE CAUSE OF THE EVENT. COMPLAINTS REPORTED RELATED TO THE 12 PATIENTS IN TABLE 1 HAVE BEEN SUBMITTED UNDER INDIVIDUAL MDRS. FOR COMPLAINTS RELATED TO THE 22 PATIENTS LISTED IN TABLE 2 (MAUDE SEARCH DATA), EXACTECH WAS ABLE TO DEFINITIVELY MATCH 18 OF THE 22 TO COMPLAINTS WITHIN THE EXACTECH GLOBAL COMPLAINT HANDLING SYSTEM. THE IDENTIFIED COMPLAINTS ARE AS FOLLOWS: PATIENT # (B)(6), COMPLAINT # (B)(4), MDR # 1038671-2012-00042. (B)(6), (B)(4), 1038671-2013-00047. (B)(6), (B)(4), 1038671-2015-00127. (B)(6), (B)(4), 1038671-2016-00371. (B)(6), (B)(4), 1038671-2016-00509. (B)(6), (B)(4), 1038671-2016-00838. (B)(6), (B)(4), 1038671-2018-00276. (B)(6), (B)(4), 1038671-2018-00288. (B)(6), (B)(4), 1038671-2018-00480. (B)(6), (B)(4), 1038671-2018-00607. (B)(6), (B)(4), 1038671-2018-00767. (B)(6), (B)(4), 1038671-2018-00778. (B)(6), (B)(4), 1038671-2018-00828. (B)(6), (B)(4), 1038671-2018-00925. (B)(6), (B)(4), 1038671-2019-00054. (B)(6), (B)(4), 1038671-2019-00266. (B)(6), (B)(4), 1038671-2019-00326. (B)(6), (B)(4), 1038671-2019-00301. (B)(6), (B)(4), 1038671-2019-00281. WHILE THE REMAINING THREE PATIENTS COULD NOT BE DEFINITIVELY MATCHED TO EXISTING COMPLAINTS WITHIN THE EXACTECH COMPLAINTS SYSTEM, A SEARCH OF THE MAUDE DATABASE CONFIRMS THAT ALL EVENTS RELATED TO GXL CONTAINED WITHIN MAUDE WERE REPORTED BY EXACTECH. THEREFORE, IT IS REASONABLE TO CONCLUDE THAT ALL PATIENT EVENTS REPORTED IN TABLE 2 (MAUDE DATA) HAVE BEEN CAPTURED AND REPORTED AS APPROPRIATE BY EXACTECH.

    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. AS REPORTED BY THE LITERATURE ARTICLE ¿EARLY POLYETHYLENE FAILURE IN A MODERN TOTAL HIP PROSTHESIS¿, THE EXACTECH CONNEXION GXL LINER MAY BE PRONE TO A HIGH RATE OF EARLY FAILURE 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 CONNEXION GXL. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ARTICLE AUTHORS, HOWEVER; THEY REPLIED THAT NO ADDITIONAL INFORMATION WILL BE MADE AVAILABLE. CONSIDERING THIS INFORMATION IS MULTIFACTORIAL AND SPECIFIC INFORMATION COULD NOT BE REVIEWED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION AS TO THE CAUSE OF THE EVENT. COMPLAINTS REPORTED RELATED TO THE 12 PATIENTS IN TABLE 1 HAVE BEEN SUBMITTED UNDER INDIVIDUAL MDRS. FOR COMPLAINTS RELATED TO THE 22 PATIENTS LISTED IN TABLE 2 (MAUDE SEARCH DATA), EXACTECH WAS ABLE TO DEFINITIVELY MATCH 18 OF THE 22 TO COMPLAINTS WITHIN THE EXACTECH GLOBAL COMPLAINT HANDLING SYSTEM. THE IDENTIFIED COMPLAINTS ARE AS FOLLOWS: PATIENT # (B)(6), COMPLAINT # (B)(4), MDR # 1038671-2012-00042. (B)(6), (B)(4), 1038671-2013-00047. (B)(6), (B)(4), 1038671-2015-00127. (B)(6), (B)(4), 1038671-2016-00371. (B)(6), (B)(4), 1038671-2016-00509. (B)(6), (B)(4), 1038671-2016-00838. (B)(6), (B)(4), 1038671-2018-00276. (B)(6), (B)(4), 1038671-2018-00288. (B)(6), (B)(4), 1038671-2018-00480. (B)(6), (B)(4), 1038671-2018-00607. (B)(6), (B)(4), 1038671-2018-00767. (B)(6), (B)(4), 1038671-2018-00778. (B)(6), (B)(4), 1038671-2018-00828. (B)(6), (B)(4), 1038671-2018-00925. (B)(6), (B)(4), 1038671-2019-00054. (B)(6), (B)(4), 1038671-2019-00266. (B)(6), (B)(4), 1038671-2019-00326. (B)(6), (B)(4), 1038671-2019-00301. (B)(6), (B)(4), 1038671-2019-00281. WHILE THE REMAINING THREE PATIENTS COULD NOT BE DEFINITIVELY MATCHED TO EXISTING COMPLAINTS WITHIN THE EXACTECH COMPLAINTS SYSTEM, A SEARCH OF THE MAUDE DATABASE CONFIRMS THAT ALL EVENTS RELATED TO GXL CONTAINED WITHIN MAUDE WERE REPORTED BY EXACTECH. THEREFORE, IT IS REASONABLE TO CONCLUDE THAT ALL PATIENT EVENTS REPORTED IN TABLE 2 (MAUDE DATA) HAVE BEEN CAPTURED AND REPORTED AS APPROPRIATE BY EXACTECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127390 EXACTECH, INC. GXL LINERS JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention