BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAXERA 58MM ACETABULUM

    MDR report key: 15614717 · Received October 17, 2022

    Report

    Report Number
    0001822565-2022-02976
    Event Type
    Injury
    Date Received
    October 17, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN SOURCE: CANADA. DOI: HTTPS://DOI.ORG/10.1186/S12891-022-05082-6. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED MAXERA CUP WITH THE LINER AND SHELL SEPARATED. DARK DEBRIS AND WEAR IS SEEN ON THE SHELL AND LINER, AS WELL AS DARK TISSUES IN THE JOINT. THE PRODUCT IS COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURE IN THE JOURNAL ARTICLE (FIGURES 8 AND 9). RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LOOSENING OF THE HARDWARE NOTED BETWEEN THE ACETABULAR SHALL AND THE CERAMIC LINER. THIS INDICATES LOOSENING OF THE HARDWARE. INTRA-ARTICULAR GAS IS NOTED, SUGGESTING INFECTIOUS CAUSE AND THEREFORE THE LOOSENING MAY BE RELATED TO INFECTION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A CLINICAL STUDY, A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE, DUE TO PRIMARY OSTEOARTHRITIS. SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION WHICH REVEALED A PARTIALLY OPENED POSTERIOR CAPSULE WITH A LARGE AMOUNT OF YELLOW FLUID, THE LINER WAS MISALIGNED WITHOUT MOBILIZATION, TAPER MODULAR JUNCTION WEAR, AND SIGNS OF CORROSION. THE MAXERA CUP WAS REMOVED AND REPLACED WITH A 2MM LARGER CUP, WITH TWO SCREWS AND A 40MM CERAMIC INSERT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2944246 UNK MAXERA 58MM ACETABULUM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R UNK BIOLOX DELTA FEMORAL HEAD 44MM| UNK BIOLOX DELTA TAPER LINER| UNK TITANIUM SHELL