BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN JIGS PREF L

    MDR report key: 7434717 · Received April 16, 2018

    Report

    Report Number
    0009617840-2018-00004
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ZIMMER CAS
    Product Code
    JWH
    PMA / PMN Number
    PK131409
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF IMAGING PROVIDED. ALTHOUGH THE PATIENT DIAGNOSTIC WAS CONFIRMED THROUGH REVIEW OF THE POST-OPERATIVE X-RAY, NO DEVICE DEFICIENCY COULD BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE TIBIAL JIG OUTPUTTED BY THE JIG CREATION APPLICATION WAS ASSESSED AND NOTHING UNUSUAL WAS OBSERVED. THE JIG CREATION SOFTWARE VERSION USED FOR THIS CASE WAS A VALIDATED SOFTWARE VERSION. ALL THE STEPS WERE COMPLETED AS PER APPLICABLE WORK INSTRUCTIONS AND NO NC OR DEVIATION WERE RECORDED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CAS PSI BONE MODELS, CATALOG #: 20-8070-009-00, LOT#: 63935700. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE CUSTOM PRODUCT CAN BE RECREATED BY THE MANUFACTURER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009617840-2018-00004, 00005.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS IN VARUS ALIGNMENT FOLLOWING SURGERY WITH CUSTOMIZED CUT GUIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277528 PSN JIGS PREF L PROSTHESIS, KNEE JWH ZIMMER CAS N/A 63935701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other