BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N-K II ULTRACONGRUENT TIBIAL INSERT

    MDR report key: 5306565 · Received December 17, 2015

    Report

    Report Number
    2648920-2015-00436
    Event Type
    Injury
    Date Received
    December 17, 2015
    Report Date
    December 1, 2015
    Manufacturer
    ZIMMER B.V.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATALOG #621201220, N-K II STEMMED TIBIAL COMPONENT, LOT #60697197; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4); CATALOG #621200021, N-K II FEMORAL COMPONENT, LOT #60734989; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4). NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO DEVIATIONS/ANOMALIES IDENTIFIED. THESE DEVICES ARE USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THE PART AND LOT COMBINATION OF ANY OF THE COMPONENTS. REVIEW OF THE PRIMARY NOTES FOUND THAT THE OPERATED KNEE HAD GOOD MOBILITY WITH 0-130 DEGREES, GOOD STABILITY AND NO FRONTAL LAXITY. NO LOOSENING 5 YEARS POST SURGERY. IN A 2015 LETTER TO HER PRIMARY SURGEON, THE PATIENT STATED THAT SHE CONSULTED ANOTHER SURGEON WHO CONCLUDED THAT THERE IS AN EARLY AND ABNORMAL WEAR OF THE PROSTHESIS. THE PATIENT ALSO REFERS TO WEAR DEBRIS AS WELL AS DAMAGED AND WEAKENED KNEE BONE. PER THE NATURAL-KNEE II SYSTEM PACKAGE INSERT, PAIN, TISSUE REACTIONS AND ALLERGIES TO WEAR PRODUCTS ARE KNOWN ADVERSE EFF

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND IMPLANT WEAR WITH PARTICLES OF THE PRODUCT CIRCULATING IN THE PATIENT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833781 N-K II ULTRACONGRUENT TIBIAL INSERT JWH JWH ZIMMER B.V. 60734989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R