BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS TIB BRG 79/83X10

    MDR report key: 5937612 · Received September 8, 2016

    Report

    Report Number
    0001825034-2016-03525
    Event Type
    Injury
    Date Received
    September 8, 2016
    Report Date
    January 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 1825034-2016-03524 / 03525). REMAINS IMPLANTED.

    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: VNGD FEM - CATALOGUE 183114, LOT 918170. BIOMET TIBIAL TRAY - CATALOGUE 141225, LOT J3358284. PATELLA - CATALOGUE 184770, LOT 170600. VANGUARD FEM PEGS - CATALOGUE 183099, LOT 347400.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING RIGHT KNEE PAIN AND INSTABILITY APPROXIMATELY TWO YEARS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588309 E1 VNGD PS TIB BRG 79/83X10 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 356560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other