BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY

    MDR report key: 7339001 · Received March 14, 2018

    Report

    Report Number
    0001825034-2018-01298
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    July 6, 2015
    Report Date
    March 16, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 183004 VANGUARD CR ILOK FEM-RT 60 LOT 638930, EP-183424 E1 VNGD CR TIB BRG 63/67X14 LOT 923900, 11-150826 BMET ARCOM AP PAT W/WIRE 31MM LOT 615880, 402282 COBALT HV BONE CEMENT 40G LOT 030820. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION OPERATIVE NOTES INDICATE THAT THE SURGEON NOTED EVIDENCE OF A SMALL JOINT EFFUSION FOLLOWING THE INITIAL PROCEDURE. THE OPERATIVE NOTES INDICATED ELEVATED WHITE BLOOD CELL COUNT INDICATING INFECTION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001825034 - 2018 -01295, 0001825034 - 2018 -01296, 0001825034 - 2018 -012974.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVISION OPERATIVE NOTES INDICATE THAT THE SURGEON NOTED EVIDENCE OF A SMALL JOINT EFFUSION FOLLOWING THE INITIAL PROCEDURE. THE OPERATIVE NOTES INDICATED ELEVATED WHITE BLOOD CELL COUNT, BUT INFECTION COULD NOT BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION POST-PRIMARY RIGHT KNEE IMPLANTATION. THE FLUID WAS DRAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180604 BIOMET CC I-BEAM TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3362978

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR