BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK AGC V2 TIBIAL COMPONENT

    MDR report key: 7167127 · Received January 5, 2018

    Report

    Report Number
    3002806535-2018-00046
    Event Type
    Injury
    Date Received
    January 5, 2018
    Report Date
    January 5, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). E. KOSKINEN, P. PAAVOLAINEN, P. YLINEN, A. ESKELINEN, A. HARILAINEN, J. SANDELIN, K. TALLROTH, V. REMES (2010) ¿MID-TERM RESULTS FOR THREE CONTEMPORARY TOTAL KNEE REPLACEMENT DESIGNS ¿ A COMPARATIVE STUDY OF 104 PATIENTS WITH PRIMARY OSTEOARTHRITIS" . SCANDINAVIAN JOURNAL OF SURGERY 99: 250¿255, 2010, HTTP://JOURNALS.SAGEPUB.COM/DOI/PDF/10.1177/145749691009900414. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED UPON REVIEW OF JOURNAL ARTICLE ENTITLED " MID-TERM RESULTS FOR THREE CONTEMPORARY TOTAL KNEE REPLACEMENT DESIGNS ¿ A COMPARATIVE STUDY OF 104 PATIENTS WITH PRIMARY OSTEOARTHRITIS" BY KOSKINEN, E. ET AL. (2010). NINE REVISION SURGERIES WERE REPORTED IN THE JOURNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12356 UNK AGC V2 TIBIAL COMPONENT KNEE PROSTHESIS JWH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R