BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR MONO-LOCK BEARING 16X83

    MDR report key: 3203315 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02470
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    July 9, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK060525
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION INCLUDING PRODUCT IDENTIFICATION AND REVISION SURGERY DETAILS. 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 WARNINGS STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INSTABILITY. THE TIBIAL BEARING WAS REMOVED AND REPLACED WITH A THICKER BEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, IT IS REPORTED PATIENT IS RECOMMENDED FOR A REVISION DUE TO POSTERIOR CAPSULAR LAXITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301832 VANGUARD CR MONO-LOCK BEARING 16X83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 457010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R