BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAXERA ACETABULAR SYSTEM

    MDR report key: 15596227 · Received October 13, 2022

    Report

    Report Number
    0001822565-2022-02944
    Event Type
    Injury
    Date Received
    October 13, 2022
    Report Date
    October 11, 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BILATERAL TOTAL HIP ARTHROPLASTIES WITH PRESENCE OF A ROUNDED LUCENCY ALONG THE RIGHT GREATER TROCHANTER MEASURING 9.1 X 2.8 X 3.5 CM IN SIZE WHICH IS NO LONGER SEEN 12 MONTHS AFTER THE EVENT. THIS PRESUMABLY RELATES TO THE PATIENT'S PNEUMOARTHROSIS AND CERAMIC LINER DISIMPACTION DESCRIBED IN THE PATIENT'S HISTORY. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. DOI: HTTPS://DOI.ORG/10.1186/S12891-022-05082-6.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE APPROXIMATELY 5 YEARS POST BILATERAL TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED SUDDEN HIP PAIN ON AN UNKNOWN SIDE WHILE WALKING. RADIOGRAPHIC EVIDENCE DISPLAYED PNEUMARTHROSIS WITH SUSPICION OF CERAMIC LINER DISIMPACTION OF THE RIGHT TOTAL HIP ARTHROPLASTY. SYMPTOMS IMPROVED AND CONSERVATIVE MEASURES WERE TAKEN. APPROXIMATELY 12 MONTHS LATER, THE PATIENT CONTINUES TO BE PAIN FREE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566168 UNKNOWN MAXERA ACETABULAR SYSTEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| O UNK BIOLOX HEAD| UNK BIOLOX TAPER| UNK STEM