BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL/XLAT POR PROFILE

    MDR report key: 8285023 · Received January 29, 2019

    Report

    Report Number
    0001825034-2019-00382
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    November 16, 2016
    Report Date
    March 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: US157856 M2A MAGNUM PF CUP 510970, 157450 M2A MAGNUM MODULAR HEAD 744450, 139256 M2A MAGNUM TAPER INSERT 221610. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION DUE TO PAIN AND LOOSENING ELEVATED ION LEVELS, BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80704 INTEGRAL/XLAT POR PROFILE PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 397330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R