BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4945428 · Received July 28, 2015

    Report

    Report Number
    0001825034-2015-03301
    Event Type
    Injury
    Date Received
    July 28, 2015
    Report Date
    July 10, 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
    BE
    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. 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; (B)(6); 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. THIS INFORMATION WAS ORIGINALLY REPORTED ON 1825034-2015-03285 WHICH REFERENCED A JOURNAL ARTICLE WRITTEN ON A STUDY THAT THIS PATIENT TOOK PART IN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "THE OXFORD UNICOMPARTMENTAL KNEE PROSTHESIS: AN INDEPENDENT 10-YEAR SURVIVAL ANALYSIS" VORLAT, P. ET AL. KNEE SURG SPORTS TRAUMATOL ARTHROSC (2006) 14: 40-45 DOI: 10.1007/S00167-005-0621-1. IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN SIDE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO UNKNOWN REASON 60 MONTHS FOLLOWING THE INITIAL PROCEDURE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490098 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R