BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 6908683 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07355
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 23, 2011
    Report Date
    October 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AARON J. JOHNSON, SIRAJ A. SAYEED, QAIS NAZIRI, HARPAL S. KHANUJA, MICHAEL A. MONT ¿MINIMIZING DYNAMIC KNEE SPACER COMPLICATIONS IN INFECTED REVISION ARTHROPLASTY¿ CLIN ORTHOP RELAT RES (2012) 470:220-227. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. X-RAYS AND X-RAY REVIEW WAS NOTED IN THE JOURNAL ARTICLE THAT SAYS "AP AND LATERAL RADIOGRAPHS OF THE KNEE APPROXIMATELY 4 WEEKS AFTER SPACER PLACEMENT WITH PAIN AND SWELLING OF THE KNEE, SHOW A FRACTURED FEMORAL COMPONENT WITH INSUFFICIENT CEMENT ANTERIORLY AND POSTERIORLY, WHICH LED TO THE GENERATION OF A CANTILEVERED BENDING MOMENT ON WEIGHTBEARING AND ULTIMATELY FRACTURE OF THE POSTERIOR CONDYLE" IT WAS NOTED IN THE JOURNAL ARTICLE THAT PATIENTS WERE ADVISED TO BE PARTIAL WEIGHT BEARING POST-OP HOWEVER IT WAS STATED THAT "PATIENTS WHO HAD SPACER FRACTURES ADMITTED TO FULL WEIGHT BEARING". ADDITIONALLY, THE IFU STATES THAT "THE PATIENT IS TO BE WARNED THAT THERE IS A HIGH RISK OF CEMENT SPACER FRACTURE UPON FULL WEIGHT BEARING OR HIGH ACTIVITY". FROM THIS IT CAN BE DETERMINED THAT THE ROOT CAUSE OF THE EVENT IS RELATED TO OPERATIONAL CONTEXT/PATIENT ACTIVITY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT HAD A FRACTURED FEMORAL COMPONENT 4 WEEKS POST OP AND EXHIBITED PAIN AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687874 UNKNOWN KNEE FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention