BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT G-HV BONE CEMENT 40G

    MDR report key: 11706245 · Received April 22, 2021

    Report

    Report Number
    0001825034-2021-01205
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    November 12, 2020
    Report Date
    August 24, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FINDINGS: LOOSE TIBIAL COMPONENT, PRESUMED ASEPTIC LOOSENING, REVISION ALL COMPONENTS EBL 300ML NO ACUTE INFLAMMATION NOTED REVISION OF ALL COMPONENTS (EXCEPT PATELLA) WITHOUT SIGNIFICANT FINDINGS OR COMPLICATIONS DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED PRODUCTS : ITEM#: 141233; BIOMET CC CRUCIATE TRAY 71MM LOT#: J3496987. ITEM#: 183024; VANGUARD CR ILOK FEM-LT 60 LOT#: 882490. 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 BEEN DISCARDED. 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 - 01206 . 0001825034 - 2021 - 01207.

    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
    603264 COBALT G-HV BONE CEMENT 40G BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 576740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10