BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE-DUMMY IMPLANT

    MDR report key: 9225807 · Received October 23, 2019

    Report

    Report Number
    1020279-2019-03714
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    October 2, 2019
    Report Date
    February 12, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT WHO FELL AND BECAME INFECTED. ALL IMPLANTS WERE REMOVED. THE AFFECTED DEVICES, USED IN TREATMENT, WERE NOT RETURNED FOR EVALUATION. THEREFORE A PRODUCT ANALYSIS COULD NOT BE PERFORMED. SMITH AND NEPHEW HAS BEEN UNABLE TO OBTAIN DEVICE DETAILS. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD, COMPLAINT HISTORY AND STERILIZATION DOCUMENTATION REVIEW CANNOT BE COMPLETED. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICES FAILED TO MEET SPECIFICATIONS. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICES AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. NO MEDICAL DOCUMENTS WERE RECEIVED FOR INVESTIGATION. HOWEVER, AN INFECTION STATUS POST A TRAUMATIC FALL WAS THE ROOT CAUSE OF THE FIRST STAGE REVISION WITH SPACERS. THE PATIENT IMPACT BEYOND THE REPORTED FALL, INFECTION AND REVISION COULD NOT BE DEFINITIVELY CONCLUDED. NO FURTHER MEDICAL ASSESSMENT CAN BE PERFORMED AT THIS TIME. WITHOUT THE RETURN OF THE ACTUAL PRODUCTS INVOLVED AND NO PATIENT MEDICAL RECORDS AVAILABLE, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD A SZ 10 JLL CR OX FEMUR, SZ 7 TIBIA, 12 MM CR POLY, 35 PATELLA, FELL AND BECAME INFECTED. ALL IMPLANTS WERE REMOVED AND A SZ 8 LDK CR FEMUR, AND A SZ 7 15 MM CR ALL POLY WERE IMPLANTED AS A SPACER UNTIL INFECTION CLEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019893 KNEE-DUMMY IMPLANT PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. UNKNOWN/UNREADABLE

    Patients

    Seq Age Sex Outcome Treatment
    1