BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 15502703 · Received September 29, 2022

    Report

    Report Number
    1038671-2022-01195
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 1, 2022
    Report Date
    February 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WAS THIS DEVICE SERVICED BY A THIRD PARTY?: NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - INVESTIGATION RESULTS- PROSTHESIS WEAR, OSTEOLYSIS, AND RISK CRITERIA FOR EARLY WEAR CANNOT BE CONFIRMED AS LIMITED INFORMATION WAS PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE PENDING REVISION REPORTED IS DUE TO EARLY PROSTHESIS WEAR/OSTEOLYSIS. THE GXL LINER HAS ALREADY BEEN PHASED OUT OF THE US MARKET.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, WHO HAD INITIAL BILATERAL TOTAL HIP ARTHROPLASTY TO HIS HIPS IN APPROXIMATELY 2017 USING NOVATION CROWN, INDICATED AN ISSUE WITH THE PREMATURE WEAR OF THE POLYETHYLENE, CROSS LINKED EXACTECH CONNEXION GXL LINERS, WHICH LED TO THE PLAINTIFF¿S PREMATURE, DEBILITATING OSTEOLYSIS. THEY EXPERIENCED SEVERE PAIN AND DISCOMFORT IN BOTH HIS HIPS. A TOTAL BILATERAL HIP ARTHROPLASTY REVISION WAS RECOMMENDED BY HIS MEDICAL PROFESSIONALS. DUE TO PREMATURE WEAR AND/OR LOOSENING OF THE PRODUCT, PLAINTIFF IS SCHEDULED FOR BILATERAL REVISION SURGERY TO BE PERFORMED IN APPROXIMATELY (B)(6) 2022. THIS CASE IS TO INVESTIGATE THE LEFT HIP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910386 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention