BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF KNEE PH3 I/M ROD RMVL HK L HK

    MDR report key: 14236273 · Received April 28, 2022

    Report

    Report Number
    3002806535-2022-00235
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 25, 2022
    Report Date
    June 17, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE CLIENT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR AN INVESTIGATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS CONCLUDED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED THROUGH THE PHOTOGRAPHS PROVIDED. THE DEVICE HAS NOT BEEN RETURNED FOR FURTHER EVALUATION. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT 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

    IT WAS REPORTED, THAT: THE INSTRUMENT BROKE WHEN BEING USED. ANOTHER INSTRUMENT WAS USED FROM ANOTHER SET. THERE WAS A 10-MINUTE DELAY. PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473687 OXF KNEE PH3 I/M ROD RMVL HK L HK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB120401
    795011 OXF KNEE PH3 I/M ROD RMVL HK L HK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB120401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown