BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI TIB BRNG 12X79/83

    MDR report key: 3090409 · Received May 2, 2013

    Report

    Report Number
    0001825034-2013-01241
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 1997. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO POLY WEAR. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191985 MAX PRI TIB BRNG 12X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 803010

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R