BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI PH3 SPH CUTTER MED

    MDR report key: 7796893 · Received August 20, 2018

    Report

    Report Number
    3002806535-2018-00976
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 4, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE CONDITION OF THE SPHERICAL CUTTER INDICATES THAT THE CUTTERS HAVE BEEN USED IN MULTIPLE SURGERIES AND AS A RESULT BECAME BLUNT. 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 THAT THE REAMER IS DULL. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO INJURY TO THE PATIENT, BODY OR HEALTH

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT OCCURRED IN (B)(6). 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 THAT THE REAMER IS DULL. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO INJURY TO THE PATIENT, BODY OR HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637551 OXF UNI PH3 SPH CUTTER MED KNEE PROSTHESIS LXH BIOMET UK LTD. ZB130802

    Patients

    Seq Age Sex Outcome Treatment
    1