BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL KNEE REPLACEMENT

    MDR report key: 6092002 · Received November 10, 2016

    Report

    Report Number
    3004105610-2016-00098
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INCORRECT DETAILS ON A PATIENT CUSTOM IMPLANT LABEL INVOLVING A TKR WAS REPORTED. THE LABEL ISSUE WAS DETECTED BY THE COMPANY REPRESENTATIVE WHO REMOVED THE INCORRECT LABEL. THE REMAINING 4 PATIENT LABELS WERE CONFIRMED AS CORRECT AND WERE SUFFICIENT FOR THE HOSPITAL'S REQUIREMENTS. THE CUSTOM IMPLANT WAS SUCCESSFULLY IMPLANTED WITH NO REPORTED COMPLICATIONS. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO A MANUFACTURING ISSUE. ON INITIAL RECEIPT OF THE REPORTED EVENT, THE EVENT DESCRIPTION WAS REVIEWED AND WITH THE LIMITED INFORMATION AVAILABLE AT THAT TIME, A DECISION WAS MADE TO REPORT THE EVENT. HOWEVER, ON COMPLETION OF THE INVESTIGATION INTO THE REPORTED EVENT IT CAN NOW BE CONCLUDED THAT THE INCIDENT DOES NOT MEET THE THREE BASIC REPORTING CRITERIA REFERENCED IN 21 CFR PART 803 AS A MARKETED DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR A MARKETED DEVICE HAS NOT MALFUNCTIONED WHERE THE MALFUNCTION OF THE DEVICE OR A SIMILAR MARKETED DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA - PIN 200760 CORRECTED TO LIMB SALVAGE SYSTEM . THE 510K# - K120992 CORRECTED TO K140900.

    Additional Manufacturer Narrative · 1

    THE OPERATION WAS CARRIED OUT SUCCESSFULLY. THE FOUR CORRECT LABELS THAT WERE AVAILABLE WAS SUFFICIENT FOR THE REQUIREMENTS OF THE HOSPITAL AND THE FIFTH ONE WAS NOT REQUIRED. AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION. DEVICE IS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE STANMORE TERRITORY MANAGER THAT ON ALLOCATING THE CUSTOM IMPLANT LABELS TO THE PATIENT'S NOTES, THEATRE PROSTHESIS RECORD BOOK, STORES LOG ETC, OUT OF THE FIVE LABELS ISSUED FOUR LABELS WERE CORRECT AND ONE LABEL WAS PRINTED WITH A DIFFERENT PIN NUMBER, PATIENT NAME AND IMPLANT TYPE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00098 ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE STANMORE TERRITORY MANAGER THAT ON ALLOCATING THE CUSTOM IMPLANT LABELS TO THE PATIENT'S NOTES , THEATRE PROSTHESIS RECORD BOOK, STORES LOG ETC, OUT OF THE FIVE LABELS ISSUED FOUR LABELS WERE CORRECT AND ONE LABEL WAS PRINTED WITH A DIFFERENT PIN NUMBER, PATIENT NAME AND IMPLANT TYPE. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744528 TOTAL KNEE REPLACEMENT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 20076 PIN 20076

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other