BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEMMED TIBIAL COMPONENT

    MDR report key: 5094934 · Received September 22, 2015

    Report

    Report Number
    2648920-2015-00345
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    August 25, 2015
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THESE DEVICES ARE USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATION OF ANY COMPONENT. REVIEW OF THE OPERATIVE NOTES SUGGESTS THAT THE PROPER SURGICAL TECHNIQUE WAS EMPLOYED. OFFICE VISITS NOTES AND X-RAY IMAGES POST-SURGERY AND AT FOLLOW-UPS INDICATE THAT THE JOINT ALIGNMENT IS ANATOMIC, NO HARDWARE COMPLICATION IS EVIDENT, THE HARDWARE IS IN PLACE, THE BONE/PROSTHESIS/CEMENT INTERFACES LOOKS FINE AND THE OVERALL ALIGNMENT LOOKS PERFECT, NO FRACTURE NOTED. NO EVIDENCE OF LOOSENING OR OTHER DIFFICULTIES 22 MONTHS POST-SURGERY. THE OFFICE NOTES ALSO INDICATE THAT 9 DAYS POST-SURGERY THE PATIENT COMPLAINED OF MODERATE PAIN THAT WAS CONTROLLED WITH PAIN MEDICATION. TWO WEEKS POST-SURGERY THE PATIENT COMPLAINED OF CONSTANT PAIN IN HER KNEE THAT LIMITED HER DAILY ACTIVITIES AND DISTURBED HER SLEEP. TWENTY-TWO MONTHS POST-SURGERY SHE STILL COMPLAINED ABOUT DISCOMFORT IN HER KNEE, AGGRAVATED BY ACTIVITY. PATIENT HISTORY REVIEW FOUND THAT SHE HAS A HISTORY OF SCOLIOSIS, UNDERWENT BACK SURGERY IN 1988, AND SUFFERS FROM CHRONIC BACK PAIN. PER THE PERSONA THE PERSONALIZED KNEE SYSTEM PACKAGE INSERT, PAIN IS A KNOWN ADVERSE EFFECT ASSOCIATED WITH THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF PRODUCT OR FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG # 00597206632, NEXGEN ALL POLY PATELLA, LOT # 62376683, MANUFACTURED BY: ZIMMER INC, (B)(4). CATALOG # 42500606202, PERSONA CEMENTED FEMORAL COMPONENT, LOT # 62365187, MANUFACTURED BY ZIMMER (B)(4). CATALOG # 42522400714, PERSONA ARTICULAR SURFACE, LOT # 62199281, MANUFACTURED BY ZIMMER INC, (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING ELEVATED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627011 PERSONA STEMMED TIBIAL COMPONENT JWH JWH ZIMMER 62354490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other