BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSKPSC TIBIAL BEARING S 16X63/67

    MDR report key: 3910840 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05890
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    September 22, 2008
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 TO REMOVE AND REPLACE ALL COMPONENTS WITH CEMENT SPACER MOLDS DUE TO INFECTION. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2008 RECEIVING A BIOMET TOTAL KNEE SYSTEM. SUBSEQUENTLY, PATIENT UNDERWENT A MANIPULATION PROCEDURE ON (B)(6) 2008 DUE TO ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388574 VANGUARD SSKPSC TIBIAL BEARING S 16X63/67 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 606470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R