BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF KNEE PH3 I/M ROD RMVL HK L HK

    MDR report key: 8721415 · Received June 21, 2019

    Report

    Report Number
    3002806535-2019-00523
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 30, 2019
    Report Date
    September 17, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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 BY THE HOSPITAL THAT THE INSTRUMENT BROKE DURING A PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH ANOTHER INSTRUMENT. NO HARM TO PATIENT AND NO DELAY IN SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 BY THE HOSPITAL THAT THE INSTRUMENT BROKE DURING A PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH ANOTHER INSTRUMENT. NO HARM TO PATIENT AND NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514430 OXF KNEE PH3 I/M ROD RMVL HK L HK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1