BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY

    MDR report key: 8791535 · Received July 15, 2019

    Report

    Report Number
    0001825034-2019-03007
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    November 4, 2015
    Report Date
    December 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXPLANT DATE - THE PRODUCT WAS NOT REMOVED; THEREFORE, THIS FIELD SHOULD BE BLANK AND THE DATE INITIALLY REPORTED WAS SENT IN ERROR.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF MEDICAL RECORDS CONFIRMED THE REPORTED EVENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS ATTRIBUTED TO PROCEDURE RELATED COMPLICATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET PATELLA CATALOG # 11-150826 LOT # 189710, VANGUARD CR FEMORAL CATALOG # 183030 LOT # 231010, VANGUARD AS TIBIAL BEARING CATALOG # EP-189080 LOT # 781660, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 232350, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 156410. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-03002, 0001825034-2019-03006, 0001825034-2019-03003.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A BLOOD CLOT IN HIS LEG AND HAD TO SPEND FOUR DAYS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583646 BIOMET CC CRUCIATE TRAY PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A J3465523

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization