BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 75MM

    MDR report key: 7944401 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09539
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    February 1, 2018
    Report Date
    November 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, SWELLING AND LOOSENING OF THE TIBIAL PLATE APPROXIMATELY 5 YEARS POST SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD POSTERIOR STABILIZED INTERLOK FEMORAL COMPONENT RIGHT 72.5MM, CATALOG #: 183113, LOT #: 038480; BIOMET SERIES A STANDARD PATELLA 37MM CATALOG #: 184768, LOT #: 008140; UNKNOWN VANGUARD TIBIAL BEARING, CATALOG #: NI, LOT #: NI. IT IS UNKNOWN AT THIS TIME WHETHER ANY EXPLANTED DEVICES WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS LOOSENING OF THE TIBIAL PLATE APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785652 BIOMET CC CRUCIATE TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J2905419

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R