BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR FEMORAL COMPONENT

    MDR report key: 6118760 · Received November 21, 2016

    Report

    Report Number
    3007963827-2016-00074
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    April 11, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICES OR PHOTOS RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THIS DEVICE IS USED FOR TREATMENT. THE REVIEW OF THE PRIMARY OPERATIVE NOTES CONFIRMS THAT THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. REVIEW OF PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. THE NOTES INDICATED THAT THE COMPONENTS WERE SEQUENTIALLY CEMENTED IN PLACE. THERE WERE NO COMPATIBILITY ISSUES NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LOOSENING WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF PRODUCT OR FURTHER INFORMATION. THIS REPORT IS 1 OF 2 FOR THIS PATIENT: 0002648920-2016-03293.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT IS SCHEDULED FOR A REVISION DUE TO LOOSENING. THE DATE OF THE REVISION IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769615 NEXGEN CR FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62811996

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 00597206532 NEXGEN ALL POLY PATELLA LOT 62816494| 00597605010 NEXGEN ART SURFACE LOT 62823299| 00598005701 NEXGEN STEMMED TIBIA LOT 62846089| NEXGEN TAPER STEM PLUG LOT 62817487