BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL SPACER COMPONENT

    MDR report key: 6908413 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07502
    Event Type
    Injury
    Date Received
    October 2, 2017
    Report Date
    October 14, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT (B)(6) 2013. MEDICAL PRODUCTS - UNKNOWN TIBIAL SPACER COMPONENT; THERAPY DATE UNKNOWN. BERNARD STRUELENS, STEVEN CLAES, JOHAN BELLEMANS ¿SPACER-RELATED PROBLEMS IN TWO-STAGE REVISION KNEE ARTHROPLASTY¿ ACTA ORTHOP. BELG., 2013, 79, 422-426. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO USE ERROR/OFF-LABEL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT SEVEN PATIENTS HAD EXPERIENCED FEMORAL SPACER IMPLANT FRACTURES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688607 UNKNOWN FEMORAL SPACER COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other