BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 75MM

    MDR report key: 11725263 · Received April 26, 2021

    Report

    Report Number
    0001825034-2021-01233
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    March 22, 2019
    Report Date
    April 27, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304007512
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. MEDICAL RECORDS IDENTIFIED TIBIAL COMPONENT OBVIOUSLY LOOSE. EXPLANTED FEMORAL COMPONENT WITHOUT SUBSTANTIAL BONE LOSS. PATELLA WAS NOT 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#: 402282; COBALT HV BONE CEMENT 40G; LOT#: 058600, QTY 2. ITEM#: 184766; SERIES A 3 PEG STD 34X8.5; LOT#: 304200. ITEM#: 183128; VAN PS OPEN INTL FEM-LT 65; LOT#: J3941926. ITEM#: 183099; VANGUARD FEM PEGS SET 2; LOT#: 875950. ITEM#: EP-183642; E1 VNGD PS TIB BRG 71/75X12; LOT#: 871170. 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: 0001825034-2021-01091, 0001825034-2021-01232.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION, DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622869 BIOMET CC I-BEAM TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3958309 00880304007512

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R