BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXF ANAT BRG LT SM SIZE 3 PMA

    MDR report key: 6964265 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09373
    Event Type
    Death
    Date Received
    October 20, 2017
    Date of Event
    October 8, 2011
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT AVAILABLE FOR RETURN. NOT CLEARED FOR DISTRIBUTION IN THE US. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL PATIENT HAD AN INITIAL LEFT OXFORD KNEE PROCEDURE ON (B)(6) 2008. PATIENT REPORTED A DIAGNOSIS OF PROGRESSIVE SUPRANUCLEAR PALSY ON AN UNKNOWN DATE IN (B)(6) OF 2010 THAT IS ONGOING. PATIENT REPORTED BEING UNABLE TO KNEEL, LIMITED MOBILITY, PALSY AND OCCASIONAL FALLS ON (B)(6) 2010 WITH UNKNOWN RESOLUTION. PATIENT ALSO REPORTED CONCOMITANT DISEASE: PARKINSON'S DISEASE. THE PATIENT EXPIRED ON (B)(6) 2011 DUE TO UNKNOWN REASONS WITH THE IMPLANTS BELIEVED TO STILL BE IN SITU. NO REVISION HAS BEEN REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744851 OXF ANAT BRG LT SM SIZE 3 PMA PROTHESIS KNEE JWH ZIMMER BIOMET, INC. NI 1379723

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O