BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING 12MM X 63/67MM

    MDR report key: 6086503 · Received November 8, 2016

    Report

    Report Number
    0001825034-2016-04403
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 27, 2016
    Report Date
    February 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: BIOMET TIBIAL TRAY CATALOG 141222, LOT 357010; VANGUARD RIGHT FEMORAL CATALOG 183006, LOT 409540; BIOMET PATELLA W/WIRE CATALOG 11-150826, LOT 416000. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD FOR 183422 LOT 964160 IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: 141222, 183006, 11-150826, AND 183422. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A KNEE REVISION DUE TO UNKNOWN REASONS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TEN YEARS POST IMPLANTATION DUE TO PAIN AND A SUSPECTED LOOSE FEMORAL COMPONENT; DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE FEMORAL COMPONENT DID NO NEED REPLACED AND ONLY THE TIBIAL BEARING WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736670 VANGUARD DCM CR TIBIAL BEARING 12MM X 63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 964160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention