BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL TIB BEARING 16MM

    MDR report key: 3904138 · Received July 1, 2014

    Report

    Report Number
    0001825034-2014-05849
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    August 3, 2009
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK051570
    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS 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, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2007 FOR UNKNOWN REASONS. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 DUE TO INFECTION AND THE KNEE COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2008. IT WAS FURTHER REPORTED PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2009 DUE TO RECURRENT INFECTION. SUBSEQUENTLY, ON (B)(6) 2009, AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND THE TIBIAL BEARING WAS REMOVED AND REPLACED. ON (B)(6) 2012, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT AND THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383324 OSS AVL TIB BEARING 16MM PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 542500

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R