BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 67MM

    MDR report key: 7767015 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07531
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    November 14, 2007
    Report Date
    August 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CONTRIBUTE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-07517, 07522, 07531 & 07538.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS NOTED TO HAVE UNCONTROLLABLE MUSCLE SPASMS AND PAIN REQUIRING VISIT TO ER 16 DAYS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608470 BIOMET CC I-BEAM TRAY 67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention TIBIAL BEARING CATALOG#: 183420, LOT#: NI.| UNKNOWN PATELLAR COMPONENT.| VANGUARD FEMORAL COMPONENT, CATALOG#: 183026: