BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS FIX PIN 3.2D X 150MM STR

    MDR report key: 11700693 · Received April 21, 2021

    Report

    Report Number
    0009617840-2021-00002
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 10, 2021
    Report Date
    September 24, 2021
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K110054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PIN IN QUESTION COULD NOT BE RETURNED FOR INVESTIGATION. THE DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. X-RAYS OF THE OPERATED LEG POST OPERATION CONFIRMED THE REPORTED ISSUE OF A FRAGMENT OF A PIN BEING LOGGED IN THE FEMUR. THIS INVESTIGATOR ESTIMATES, FROM THE X-RAY PROVIDED, THAT THE FRAGMENT LENGTH AND DIAMETER ARE BOTH OF THE SAME SIZE AS THE DIAMETER OFF THE PIN OR PERHAPS LESS. IT IS NOT MENTIONED (NOR IS IT VISIBLE TO THIS INVESTIGATOR) IF THE FRAGMENT IS IN FAR CORTICAL BONE, NEAR CORTICAL BONE OR TRABECULAR BONE. A DEFINITIVE ROOT CAUSE CANNOT 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE 2-WEEK POST-OPERATIVE X-RAYS SHOW FEMORAL PIN TIP BROKE OFF INTO FEMUR. AT THIS TIME THERE IS NO PLAN TO REMOVE THE FRACTURED TIP.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597554 CAS FIX PIN 3.2D X 150MM STR INSTRUMENT, KNEE OLO ZIMMER CAS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R