BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA

    MDR report key: 8251443 · Received January 15, 2019

    Report

    Report Number
    0002648920-2019-00032
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    August 27, 2018
    Report Date
    January 22, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION ON THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. REVIEW OF THE NINE-MONTH POST-OPERATIVE NOTES IT WAS IDENTIFIED THE PATIENT BICYCLES 30 KM AND DOES STRENGTH TRAINING. THIS CAN BE OVERUSE OF IMPLANTED DEVICE AND SURROUNDING ANATOMY. PATIENT ADVISED TO MODIFY ACTIVITIES TO WHAT THE KNEE CAN TOLERATE. AT THE ONE-YEAR VISIT, PATIENT HAS NO PAIN, IS SATISFIED, AND CAN WALK 2 KM.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION ON THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. REVIEW OF THE NINE-MONTH POST-OPERATIVE NOTES IT WAS IDENTIFIED THE PATIENT BICYCLES 30 KM AND DOES STRENGTH TRAINING. THIS CAN BE OVERUSE OF IMPLANTED DEVICE AND SURROUNDING ANATOMY. PATIENT ADVISED TO MODIFY ACTIVITIES TO WHAT THE KNEE CAN TOLERATE. AT THE ONE-YEAR VISIT, PATIENT HAS NO PAIN, IS SATISFIED, AND CAN WALK 2 KM.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- NEXGEN FEMORAL COMPONENT LEFT, CATALOG # 00595601701, LOT # 63690979, NEXGEN STEMMED NONAUGMENTABLE TIBAL COMPONENT, CATALOG # 00598605701, LOT # 63656337, NEXGEN ARTICULAR SURFACE, CATALOG # 90597005010, LOT # 63726452. FOREIGN SOURCE- (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PATELLA PAIN. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43965 NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. NI 63534840

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other