BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 71MM

    MDR report key: 7770540 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-06843
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 06840 - 1, 0001825034 - 2018 - 06841 - 1, 0001825034 - 2018 - 06844 - 1.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 183008, VANGUARD CR ILOK FEM-RT 65, LOT 253600, ITEM # 183542, VNGD CR LIP TIB BRG 12X71/75, LOT 300770, ITEM # 141223, BIOMET CC I-BEAM TRAY 71MM, LOT 497390, ITEM # 184764, SERIES A PAT STD 31 3 PEG, LOT 565150. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06840, 0001825034-2018-06841, 0001825034-2018-06843, 0001825034-2018-06844.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT WAS NOTED TO HAVE DROP FOOT ON UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611009 BIOMET CC I-BEAM TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 497390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention