BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET STAGE ONE CEMENTED FEMORAL MOLD

    MDR report key: 6908408 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07509
    Event Type
    Injury
    Date Received
    October 2, 2017
    Report Date
    October 2, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2013. MEDICAL PRODUCT: BIOMET STAGE ONE CEMENTED TIBIAL MOLD, CAT#: UNKNOWN LOT#: UNKNOWN. INITIAL REPORTER: BERNARD STRUELENS, STEVEN CLAES, JOHAN BELLEMANS ¿SPACER-RELATED PROBLEMS IN TWO-STAGE REVISION KNEE ARTHROPLASTY¿ ACTA ORTHOP. BELG., 2013, 79, 422-426 REPORT SOURCE: (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07509. 0001825034-2017-07510.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOUR PATIENTS WERE REQUIRED ADDITIONAL SURGICAL INTERVENTIONS FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688601 BIOMET STAGE ONE CEMENTED FEMORAL MOLD CEMENT, BONE LOD ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R