BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IASSIST KNEE SYSTEM

    MDR report key: 6954176 · Received October 17, 2017

    Report

    Report Number
    0009617840-2017-00024
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    February 12, 2014
    Report Date
    February 5, 2018
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    PK141601
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRE- AND POST-OPERATIVE X-RAYS WERE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (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 DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE SURGEON WAS UNABLE TO VERIFY THE TIBIAL CUT WITH THE SURGICAL SYSTEM. AS A RESULT, THERE IS POOR ALIGNMENT OF THE TIBIAL COMPONENT. NO INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734727 IASSIST KNEE SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other NEXGEN LPS FLEX FIXED PN:00596404010 LN: NI| NEXGEN LPS PN: 00599201501LN: NI| NEXGEN STEMMED PN:00598004701 LN: NI| NEXGEN LPS FLEX FIXED PN:00596404010 LN: NI| NEXGEN LPS PN: 00599201501LN: NI| NEXGEN STEMMED PN:00598004701 LN: NI