BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD KNEE

    MDR report key: 3782104 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03333
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    June 12, 2013
    Report Date
    March 1, 2016
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO EVENT DETAILS AND PRODUCT IDENTIFICATION ARE IN PROCESS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03332 / 03333).

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY. PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008 AND LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S RIGHT PARTIAL KNEE WAS REVISED TO TOTAL KNEE ON (B)(6) 2013, DUE TO PAIN. PATIENT'S LEFT KNEE WAS REVISED TO TOTAL KNEE ON (B)(6) 2013, DUE TO DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260250 UNKNOWN OXFORD KNEE PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R