BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR COLLAR

    MDR report key: 9362122 · Received November 22, 2019

    Report

    Report Number
    0001825034-2019-05274
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    August 30, 2010
    Report Date
    January 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THAT THE PATIENT EXPERIENCED A FRACTURE IN THE GREATER TROCHANTER WHERE A PIN WAS PLACED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED PRODUCTS: 139258-M2A-MAGNUM-267030; 157450-M2A-MAGNUM MOD-231430; US157856-M2A-MAGNUM PF CUP-667860. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. IT WAS NOTED THERE WAS A FRACTURE IN THE GREATER TROCHANTER THAT WAS REPAIRED DURING INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154757 BI-METRIC/X POR COLLAR PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 750440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization