BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN

    MDR report key: 2004003 · Received December 23, 2010

    Report

    Report Number
    MW5019565
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 17, 2010
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT HAD AN ACL REPAIR IN WHICH A TIBIALIS ANTERIOR CRUCIATE LIGAMENT ALLOGRAFT WAS USED. PT BEGAN EXPERIENCING PAIN AND SWELLING. KNEE ASPIRATION WAS PERFORMED DEMONSTRATING LARGE AMOUNT OF CLOUDY FLUID. TESTING WAS OBTAINED TO INCLUDE CULTURES WITH NO MICROORGANISM SEEN. SHE WAS ASPIRATED SEVERAL TIMES AND WAS STARTED ON CIPRO. SHE CONTINUED WITH PAIN AND SWELLING AND WAS ADMITTED FOR SURGICAL INTERVENTION ON (B)(6) 2010. PER SURGEON, DURING SURGERY, IT WAS NOTED THAT THE GRAFT WAS FRAYED AND LOOKED BAD FROM INTRAARTICULAR VIEWPOINT. THE GRAFT WAS REMOVED AS WELL AS THE PINS. CULTURES OF GRAFT AND TISSUE WERE PERFORMED WITH NO GROWTH NOTED. PT RECEIVED EMPIRIC ANTIBIOTIC THERAPY WITH CONCURRENCE OF AN ID PHYSICIAN. MD ASSESSED PROBLEM TO BE AN IMMUNE RESPONSE TO TIBIALIS ALLOGRAFT VERSUS INTRAARTICULAR INFECTION, LATE. POSSIBLE PRODUCT PROBLEM MENTIONED: THEREFORE, REPORTING IS BEING DONE TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN PIN JWH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization LOT: # 1010517-006| (B)(4)| MFR: LIFENET HEALTH,| LIFENET HEALTH / ALLOGRAFT -TENDON| POSTERIOR TIBIALIS TENDON FROZEN