BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC KNEE

    MDR report key: 2809979 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02280
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN THE JOURNAL ARTICLE TITLED "LONG-TERM FOLLOW-UP OF ANATOMIC GRADUATED COMPONENT TOTAL KNEE ARTHROPLASTY" THE JOURNAL OF ARTHROPLASTY VOL. 27 NO. 62012 CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE REVISION MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY MAARTEN R. HUIZINGA, MD, REINOUD W. BROUWER, MD, PHD, ROEL BISSCHOP, MD, HUGO C. VAN DER VEEN, MD, INGE VAN DEN AKKER-SCHEEK, PHD, AND JOS J.A.M. VAN RAAY, MD, PHD. IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE WHICH IS ON LONG-TERM FOLLOW-UP OF ANATOMIC GRADUATED COMPONENT TOTAL KNEE ARTHROPLASTY. (B)(4). THERE IS NO FURTHER INFORMATION IN THE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN AGC KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R