BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 31 3 PEG

    MDR report key: 3960787 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06467
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06210, 06464/06467).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION ON (B)(6) 2014 DUE TO ALLEGED INFECTION. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED PATIENT UNDERWENT A WASHOUT PROCEDURE ON (B)(6) 2014 DUE TO ALLEGED INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. THERE HAS BEEN NO FURTHER REPORTED REVISION PROCEDURES TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437771 SERIES A PAT STD 31 3 PEG PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 306560

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R