BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA FEMORAL COMPONENT

    MDR report key: 4252957 · Received November 12, 2014

    Report

    Report Number
    1822565-2014-01559
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A.: REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. REVISION OPERATIVE NOTES INDICATE THE PT WAS REVISED DUE TO RECURRENT SUBLUXATION OF THE PATELLA. THE POSSIBILITY OF SOME INTERNAL ROTATION OF THE FEMUR WAS NOTED. ALL COMPONENTS WERE REVISED EXCEPT THE PATELLAR COMPONENT. NO FURTHER DESCRIPTION OF THE EXPLANTS WAS PROVIDED. REVIEW OF THE RETURNED RADIOGRAPHS CONFIRMS SUBLUXATION OF THE PATELLA. THE MEDIAL/LATERAL RADIOGRAPH DATED ON (B)(6) 2013 SUGGESTS INTERNAL ROTATION OF THE FEMORAL COMPONENT WITH RESPECT TO THE TIBIAL COMPONENT. INTERNAL ROTATION OF THE FEMORAL COMPONENT MAY CONTRIBUTE TO PATELLAR SUBLUXATION; HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED. THE PACKAGE INSERT PROVIDED WITH THE PATELLAR COMPONENT LISTS DISLOCATION AND/OR JOINT INSTABILITY AS AN ADVERSE EFFECT. THIS IS THEREFORE A KNOWN INHERENT RISK OF THE PROCEDURE. CAUSE CANNOT BE DEFINITIVELY DETERMINED.: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. THE INFO PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MFG REPORT NUMBER # 2648920-2014-00272.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO A PATELLA TRACKING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729024 PERSONA FEMORAL COMPONENT JWH ZIMMER, INC. 62332698

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PERSONA ALL POLY PATELLA, CATALOG # 42540000035,| LOT # 62394484, MANUFACTURED AT ZIMMER B.V., PONCE| PUERTO RICO