BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCM VANGUARD CR TIBIAL BEARING 10MM X 71/75MM

    MDR report key: 6148897 · Received December 6, 2016

    Report

    Report Number
    0001825034-2016-05055
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 14, 2016
    Report Date
    March 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 AND TO RELAY CORRECTED INFORMATION. CONCOMITANT PRODUCTS: VANGUARD CR RIGHT FEMORAL 67.5MM CATALOG 183010 LOT 131010; BIOMET TIBIAL TRAY CATALOG 141234 LOT 362580; BIOMET PATELLA CATALOG 11-150842 LOT 419180. PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE IS USED FOR TREATMENT. THE COMPLAINT COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ BIOMET PATELLA CATALOG 11-150842 LOT 419180. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-05055 / 05057).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO PAIN APPROXIMATELY 12 YEARS POST IMPLANTATION. THE TIBIAL AND FEMORAL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798911 DCM VANGUARD CR TIBIAL BEARING 10MM X 71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 084220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10