BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4930996 · Received July 22, 2015

    Report

    Report Number
    0001825034-2015-03191
    Event Type
    Injury
    Date Received
    July 22, 2015
    Report Date
    June 30, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 WALKER T, ET AL IN KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2014 JUN 25. 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

    KNEE SURG SPORTS TRAUMATOL ARTHROSC DOI: 10.1007/S00167-014-3111-5. WALKER, T., ET AL. INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "RETURN TO SPORTS, RECREATIONAL ACTIVITY AND PATIENT-REPORTED OUTCOMES AFTER LATERAL UNICOMPARTMENTAL KNEE ARTHROPLASTY" WHICH AIMED TO SURVEY THE ACTIVITY LEVEL AND THE HEALTH-RELATED QUALITY OF LIFE OF PATIENTS FOLLOWING LATERAL UKA USING THE OXFORD DOMED LATERAL COMPONENT MANUFACTURED AT BIOMET. THE STUDY INVOLVED FIFTY (50) PATIENTS WHO RECEIVED FIFTY (50) KNEES. THE JOURNAL ARTICLE REPORTS THE FOLLOWING REVISIONS BY BIOMET BRAND NAME AND REASON: TWO (2) REVISIONS DUE TO MOBILE BEARING DISLOCATION THE AUTHORS OF THE STUDY CONCLUDE THAT A VAST MAJORITY OF PATIENTS, INDEPENDENT OF AGE OR GENDER WERE ABLE TO RETURN TO THEIR SPORTING BEHAVIOR AFTER LATERAL UKA TO WHICH THEY WERE ACCUSTOMED BEFORE THE ONSET OF THE FIRST RESTRICTING SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475353 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R