BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANG SSK PSC TIB BRG 12X71/75

    MDR report key: 3903238 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05870
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 8 STATES: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO FRACTURED LIGAMENTS. IT WAS FURTHER REPORTED A SECOND REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO FRACTURED LIGAMENTS. ALL PRODUCTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380092 VANG SSK PSC TIB BRG 12X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 032780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R