BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN KNEE

    MDR report key: 4936799 · Received July 23, 2015

    Report

    Report Number
    0001825034-2015-03250
    Event Type
    Death
    Date Received
    July 23, 2015
    Report Date
    July 13, 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
    UK
    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 ARTICLE WAS WRITTEN BY WEALE AE ET AL. IN CLIN ORTHOP RELAT RES. 2001 JAN;(382):143-53. 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 1825034-2015-03249 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, "PERCEPTIONS OF OUTCOMES AFTER UNICOMPARTMENTAL AND TOTAL KNEE REPLACEMENTS" WEALE, A.E., ET AL. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, NUMBER 382, P. 143-153. IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT EXPERIENCED A PROCEDURAL RELATED PULMONARY EMBOLISM WHICH RESULTED IN DEATH THREE DAYS FOLLOWING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479155 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R