BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4916527 · Received July 15, 2015

    Report

    Report Number
    0001825034-2015-03004
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    October 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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 WEALE AE, MURRAY DW, BAINES J, NEWMAN JH IN J BONE JOINT SURG BR. 2000 SEP;82(7):996-1000.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "RADIOLOGICAL CHANGES FIVE YEARS AFTER UNICOMPARTMENTAL KNEE REPLACEMENT" WHICH ASSESSED THE FATE OF THE COMPARTMENTS AND CHANGES IN LEG ALIGNMENT FOLLOWING A UKR. THE STUDY WAS CONDUCTED OVER A PERIOD OF THREE (3) YEARS (1989 TO 1992) AND INVOLVED FORTY-FIVE (45) PATIENTS WHO RECEIVED FIFTY (50) UKRS. FOUR (4) PATIENTS DIED DURING THE STUDY. THE JOURNAL ARTICLE REPORTS THE FOLLOWING EVENTS BY REASON: TWO (2) REVISIONS OCCURRING BEFORE REVIEW. TWO (2) OVERCORRECTIONS OF DEFORMITY IN THE CORONAL PLANE. ONE (1) PROGRESSION OF OSTEOARTHRITIS WITHIN THE PATELLOFEMORAL JOINT. THE AUTHORS OF THE STUDY CONCLUDE THAT THE INCIDENCE OF PROGRESSIVE OSTEOARTHRITIS WITHIN THE KNEE WAS VERY LOW AFTER UKR. PATIENTS SHOULD BE CAREFULLY SELECTED AND OVERCORRECTION OF THE DEFORMITY BE AVOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460154 UNKNOWN KNEE PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R