BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL BEARING

    MDR report key: 6907274 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07486
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 23, 2011
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - UNKNOWN TIBIAL TRAY, UNKNOWN FEMORAL COMPONENT. THERAPY DATE UNKNOWN. INITIAL REPORTER: AARON J. JOHNSON, SIRAJ A. SAYEED, QAIS NAZIRI, HARPAL S. KHANUJA, AND MICHAEL A. MONT ¿MINIMIZING DYNAMIC KNEE SPACER COMPLICATIONS IN INFECTED REVISION ARTHROPLASTY¿ CLIN ORTHOP 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 UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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 AFTER REIMPLANTATION ARTHROPLASTY, A PATIENT REQUIRED SURGERY FOR HEMATOMA FORMATION, LYSIS OF ADHESIONS, AND A POLYETHYLENE EXCHANGE. ONE YEAR AFTER THIS PROCEDURE, THE PATIENT REMAINED FREE OF INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688730 UNKNOWN TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R