BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 5499274 · Received March 14, 2016

    Report

    Report Number
    0001825034-2016-00869
    Event Type
    Injury
    Date Received
    March 14, 2016
    Report Date
    February 15, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY PHILIP M. FARIS, MERRILL A. RITTER, E. MICHAEL KEATING, JOHN B. MEDING, AND LEESA D. HARTY. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED.  SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON THE REVIEW OF THE JOURNAL ARTICLE, "THE AGC ALL-POLYETHYLENE TIBIAL COMPONENT: A TEN-YEAR CLINICAL EVALUATION" WHICH AIMED TO EVALUATE THE CLINICAL AND RADIOGRAPHIC RESULTS ASSOCIATED WITH THE AGC ALL-POLYETHYLENE TIBIAL COMPONENT. THIS STUDY CONSISTS OF 405 PATIENTS WHO UNDERWENT 536 TOTAL KNEE ARTHROPLASTIES BETWEEN JUNE 18, 1990 AND NOVEMBER 14, 1991. THE ARTICLE REPORTS REVISIONS DUE TO (58) LOOSENING OR COLLAPSE BENEATH THE MEDIAL PLATEAU, (18) LOOSE PATELLAR PROSTHESIS, (3) INFECTION. IN CONCLUSION, THE FAILURE RATE ASSOCIATED WITH THIS FLAT ALL-POLYETHYLENE TIBIAL COMPONENT SUGGESTS THAT ALL-POLYETHYLENE TIBIAL COMPONENTS ARE DESIGN-SENSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155095 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R