BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 7192798 · Received January 16, 2018

    Report

    Report Number
    3002806535-2018-00085
    Event Type
    Injury
    Date Received
    January 16, 2018
    Report Date
    January 16, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDG
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PANZRAM B, BERTLICH I, REINER T, WALKER T, HAGMANN S, GOTTERBARM T (2017) CEMENTLESS OXFORD MEDIAL UNICOMPARTIMENTAL KNEE REPLACEMENT: AN INDEPENDENT SERIES WITH A 5-YEAR-FOLLOW-UP. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, JULY 2017, VOLUME 137, ISSUE 7, PP 1011¿1017, HTTPS://LINK.SPRINGER.COM/CONTENT/PDF/10.1007/S00402-017-2696-9.PDF 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 BASED ON REVIEW OF A JOURNAL ARTICLE, ENTITLED "CEMENTLESS OXFORD MEDIAL UNICOMPARTIMENTAL KNEE REPLACEMENT: AN INDEPENDENT SERIES WITH A 5-YEAR-FOLLOW-UP", BY PANZRAM, B. ET AL. (2017). THIS COMPLAINT REFERS TO THE REPORTED REVISION DUE TO REOPERATION DUE TO LOOSE CEMENT BODIES .IT WAS REVISED BY THERAPEUTIC ARTHROSCOPY WITH UNKNOWN CEMENTED FEMORAL, TIBIAL AND BEARING COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36571 UNKNOWN FEMORAL COMPONENT JDG BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R