BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 7276093 · Received February 16, 2018

    Report

    Report Number
    3002806535-2018-00361
    Event Type
    Injury
    Date Received
    February 16, 2018
    Report Date
    February 16, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OMAR FAOUR-MARTÍN , JOSE ANTONIO VALVERDE-GARCÍA ,MIGUEL ÁNGEL MARTÍN-FERRERO & AURELIO VEGA-CASTRILLO ,MARÍA ANGELES DE LA RED GALLEGO , CESAR C. SUÁREZ DE PUGA ,LUIS AMIGO-LIÑARES OXFORD PHASE 3 UNICONDYLAR KNEE ARTHROPLASTY THROUGH A MINIMALLY INVASIVE APPROACH: LONG-TERM RESULTS INTERNATIONAL ORTHOPAEDICS (SICOT) (2013) 37:833¿838, HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S00264-013-1830-8 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 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON JOURNAL ARTICLE ENTITLED "OXFORD PHASE 3 UNICONDYLAR KNEE ARTHROPLASTY THROUGH A MINIMALLY INVASIVE APPROACH: LONG-TERM RESULTS", BY OMAR FAOUR-MARTÍN, ET AL. (2013) ABSTRACT PURPOSE SURGICAL TREATMENT OPTIONS FOR MEDIAL COMPARTMENT OSTEOARTHRITIS OF THE KNEE INCLUDE HIGH TIBIAL OSTEOTOMY, TOTAL KNEE ARTHROPLASTY OR UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA), DEPENDING ON THE PATIENT¿S AGE, LEVEL OF PHYSICAL ACTIVITY AND THE DEGREE OF DEFORMITY. THIS COMPLAINT REFERS TO THE 4 KNEE REVISIONS DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT (PAGE 836, TABLE 2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121808 UNKNOWN OXFORD TIBIAL COMPONENT JWH BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R