BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD CR TIBIAL BEARING 10X63/67

    MDR report key: 3892435 · Received June 24, 2014

    Report

    Report Number
    0001825034-2014-05676
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THAT 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.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05675 / 05676).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 AND RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A BILATERAL REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN. BOTH PATELLAS WERE RESURFACED DURING THE REVISION PROCEDURE AND BOTH TIBIAL BEARINGS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367807 VANGRD CR TIBIAL BEARING 10X63/67 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 947130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R