BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF PH3 CEMENTLESS TIB SZ D LM

    MDR report key: 6910110 · Received October 3, 2017

    Report

    Report Number
    0001825034-2017-07805
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    June 17, 2008
    Report Date
    October 2, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (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 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. (B)(4). HOOPER, G.J. ET AL. J BONE JOINT SURG BR 2012;94-B:334¿8. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "THE EARLY RADIOLOGICAL RESULTS OF THE UNCEMENTED OXFORD MEDIAL COMPARTMENT KNEE REPLACEMENT." THIS STUDY CONSISTED OF ONE PATIENT WHO UNDERWENT LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED TO A TOTAL KNEE ON (B)(6) 2008 DUE TO LATERAL COMPARTMENT OSTEOTOMY. PATIENT WAS REVISED TO A TOTAL KNEE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690213 OXF PH3 CEMENTLESS TIB SZ D LM KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R