BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 5476661 · Received March 3, 2016

    Report

    Report Number
    0001825034-2016-00721
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    February 4, 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
    KS
    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 PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY I. J. KOH, J.H. KIM, S.W. JANG, M.S. KIM, C. KIM, AND Y. INA. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY.¿ PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON THE REVIEW OF THE JOURNAL ARTICLE TITLED, "ARE THE OXFORD MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY NEW INSTRUMENTS REDUCING THE BEARING DISLOCATION RISK WHILE IMPROVING COMPONENTS RELATIONSHIPS? A CASE CONTROL STUDY." THE MEDICAL RECORDS AND RADIOGRAPHS OF 71 PATIENTS WHO UNDERWENT 82 OXFORD MOBILE-BEARING UKAS (60 UNILATERAL AND 11 BILATERAL) IN THE PERIOD BETWEEN MAY 2011 AND MAY 2014 WERE SELECTED FOR RETROSPECTIVE REVIEW. IT ARTICLE REPORTED FOUR CASES OF BEARING DISLOCATION. IN CONCLUSION, USING THE UPDATED MICROPLASTY SYSTEM IN OXFORD MOBILE-BEARING UKAS REDUCES THE RISK OF BEARING DISLOCATION BY ENHANCING CONTIGUOUS COMPONENTRY RELATIONSHIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132700 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R