BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PATELLA STD 40 3 PEG

    MDR report key: 2932731 · Received January 29, 2013

    Report

    Report Number
    0001825034-2013-00161
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PAIN. IT WAS NOTED DURING THE REVISION PROCEDURE THE PATELLA WAS SHEARED OFF AT THE PEGS; THE PATELLA WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39608 SERIES A PATELLA STD 40 3 PEG PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 432640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R