BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS TIB BRG 79/83X12 OR

    MDR report key: 4577374 · Received March 6, 2015

    Report

    Report Number
    0001825034-2015-00860
    Event Type
    Injury
    Date Received
    March 6, 2015
    Report Date
    February 10, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COMPLAINT RELATED ANOMALY OR DEVIATION. AS IT IS UNKNOWN WHICH KNEE WAS REVISED AND WHAT PARTS WERE REMOVED, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - EP-183662. LOT NUMBER - 132920. EXPIRATION DATE ¿ SEP 30, 2014. MANUFACTURE DATE ¿ SEP 8, 2009. OR THE PART/LOT INFORMATION COULD BE: DEVICE BRAND NAME - E1 VNGD PS TIB BRG 79/83X10. CATALOG NUMBER - EP-183660. LOT NUMBER - 383250. EXPIRATION DATE - OCT 31, 2014. MANUFACTURE DATE ¿ OCT 23, 2009. REVIEW OF STERILIZATION CERTIFICATION FOR BOTH LOTS CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS; ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015- 00858 / 00860 & 00890).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TOTAL LEFT AND RIGHT KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, ONE OF THE PATIENT'S KNEES WAS REVISED ON (B)(6) 2010 DUE TO INFECTION AND THE PROCEDURE WAS COMPLETED WITH SPACER MOLDS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION OF THEIR RIGHT KNEE DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, THE CASE WAS CANCELLED DUE TO AN UNKNOWN REASON. IT IS UNKNOWN IF THE PATIENT WILL BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158909 E1 VNGD PS TIB BRG 79/83X12 OR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 132920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R