BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PH3 CEMENTLESS FEM SZ M

    MDR report key: 6910406 · Received October 3, 2017

    Report

    Report Number
    0001825034-2017-07806
    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
    NRA
    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

    PATIENT IDENTIFIER: (B)(6). 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. ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). HOOPER, G.J. ET AL. J BONE JOINT SURG BR 2012;94-B:334¿8. SEE ATTACHMENTS - ATTACHMENT: [THE EARLY RADIOLOGICAL RESULTS OF THE UNCEMENTED OXFORD MEDIAL COMPARTMENT KNEE REPLACEMENT.

    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
    690395 OXFORD PH3 CEMENTLESS FEM SZ M KNEE PROSTHESIS NRA ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R