BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POSTERIOR STABILIZED NARROW FEMORAL COMPONENT

    MDR report key: 6039695 · Received October 19, 2016

    Report

    Report Number
    3007963827-2016-00062
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    June 13, 2013
    Report Date
    December 14, 2015
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS ARE RETURNED FOR REVIEW SINCE THE DEVICES STILL REMAIN IMPLANTED IN THE PATIENT; THEREFORE, THE CONDITION OF THE FEMORAL COMPONENT IS UNKNOWN AND AN EVALUATION IS NOT POSSIBLE. THESE DEVICES ARE USED FOR TREATMENT. THE COMPLAINT HISTORY SEARCH PERFORMED INDIVIDUALLY FOR THE PART AND LOT COMBINATION OF FEMORAL, TIBIAL, ARTICULAR SURFACE AND PATELLA COMPONENT FOUND NO OTHER COMPLAINTS. THE FOLLOW UP FOR MORE INFORMATION STATED THAT THE PATIENT WAS NOT REVISED. PER THE KNEE COMPATIBILITY MATRIX THE NATURAL KNEE PATELLA IS NOT COMPATIBLE WITH THE PERSONA TIBIAL, FEMORAL AND ARTICULAR SURFACE COMPONENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN INCOMPATIBLE PATELLA WAS IMPLANTED. IT WAS FURTHER REPORTED, THE PATIENT WAS NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693891 PERSONA POSTERIOR STABILIZED NARROW FEMORAL COMPONENT KNEE PROTHESIS JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62028438

    Patients

    Seq Age Sex Outcome Treatment
    1 Other