BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC V2 CR

    MDR report key: 2798004 · Received October 22, 2012

    Report

    Report Number
    0001825034-2012-02089
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 28, 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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN THE JOURNAL ARTICLE TITLED "RESULTS OF TOTAL KNEE REPLACEMENT WITH A CRUCIATE-RETAINING MODEL FOR SEVERE VALGUS DEFORMITY "A STUDY OF 48 PATIENTS FOLLOWED FOR AN AVERAGE OF 9 YEARS." THE KNEE, JUNE 2011- VOLUME 18, ISSUE 3 PAGES 145-150. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE REVISION MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY ESA KOSKINEN, VILLE REMES, PEKKA PAAVOLAINEN, ARSI HARILAINEN, JERKER SANDELIN, KAJ TALLROTH, JYRKI KETTUNEN, PEKKA YLINEN. MANUFACTURE DATE - UNKNOWN. 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

    IT WAS REPORTED BY JOURNAL ARTICLE PATIENT UNDERWENT PRIMARY KNEE ARTHROPLASTY IN 2000. SUBSEQUENTLY, PATIENT WAS REVISED FOUR YEARS LATER DUE TO A PERIPROSTHETIC FRACTURE AFTER A FALL. NO FURTHER INFORMATION IS AVAILABLE FROM THE JOURNAL ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN AGC V2 CR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R