BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD KNEE

    MDR report key: 5507449 · Received March 17, 2016

    Report

    Report Number
    3002806535-2016-00121
    Event Type
    Injury
    Date Received
    March 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER PMA NUMBER P010014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY IN (B)(6) 2016. IT WAS FURTHER REPORTED THAT A REVISION PROCEDURE HAS BEEN INDICATED DUE TO TIBIAL FRACTURE; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163491 UNKNOWN OXFORD KNEE PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention