BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 11706248 · Received April 22, 2021

    Report

    Report Number
    0001825034-2021-01206
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    November 12, 2020
    Report Date
    May 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. PRIMARY OPERATIVE NOTES PROVIDED STATE THAT THERE WERE NO INTRA-OP COMPLICATIONS. REVISION OPERATIVE NOTES STATE THAT PATIENT WAS REVISED DUE TO LOOSENING AND ALL COMPONENTS WERE REVISED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED PRODUCTS : ITEM#: 183024; VANGUARD CR ILOK FEM-LT 60 LOT#: 882490. ITEM#: 402283; COBALT G-HV BONE CEMENT 40G LOT#: 576740. ITEM#: 189060; VNGD ANT STBLZD BRG 10X71 LOT#: 323410. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT'S LOCATION IS UNKNOWN. 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 - 2021 - 01207 . 0001825034 - 2021 - 01205.

    Description of Event or Problem · 1

    INITIAL LEFT TOTAL KNEE ARTHROPLASTY PERFORMED APPROXIMATELY 6 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED 5.5 YEARS LATER DUE TO ASEPTIC LOOSENING. ALL TIBIAL AND FEMORAL COMPONENTS WERE REVISED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603266 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3496987

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R