BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAXERA 58MM ACETABULUM

    MDR report key: 15614722 · Received October 17, 2022

    Report

    Report Number
    0001822565-2022-02975
    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). REPORT SOURCE CANADA. DOI: HTTPS://DOI.ORG/10.1186/S12891-022-05082-6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 IN A JOURNAL ARTICLE APPROXIMATELY 44 MONTHS POST LEFT TOTAL HIP ARTHROPLASTY THE PATIENT EXPERIENCED A LOUD NOISE ON THE LEFT SIDE AND FELT A SHOCK AND ACUTE PAIN IN THE LEFT LIMB. RADIOGRAPHIC EVIDENCE DISPLAYED PNEUMARTHROSIS LATERALLY TO THE ACETABULUM, WHICH REABSORBED OVER A TWO MONTH SPAN. TWO MONTHS AFTER THE INCIDENT, THE PATIENT UNDERWENT A REVISION AND FOUND THE CERAMIC LINER SLIGHTLY DISPLACED IN THE METAL CUP BUT REMAINED STABLE. TAPER MODULAR JUNCTION WEAR AND CORROSION SIGNS WERE OBSERVED. THE MAXERA CUP WAS REMOVED AND REPLACED WITH A 2MM LARGER CUP. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2944251 UNK MAXERA 58MM ACETABULUM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R UNK BIOLOX DELTA FEMORAL HEAD 48MM| UNK BIOLOX DELTA TAPER LINER| UNK TITANIUM SHELL