BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY TIBIA BASE NP RT SZ 3

    MDR report key: 8519384 · Received April 16, 2019

    Report

    Report Number
    1020279-2019-01583
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    May 31, 2018
    Report Date
    October 30, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010554277
    PMA / PMN Number
    K042515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND C-242749, C-242743, C- 242747)- IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO EXCESSIVE LACK OF MOTION, PAIN AND INFECTION. (C-242749, C-242743, C- 242747)- THE EXACT CAUSE OF THE REPORTED INFECTION COULD NOT BE DETERMINED BASED SOLELY ON THE INFORMATION PROVIDED). (C-243190,C-242737,C-242704)- IT WAS FURTHER REPORTED THE PATIENT PRESENTED ARTHROFIBROSIS OF THE RIGHT KNEE WITH SEVERE LIMITED RANGE OF MOTION AND DEVELOPMENT OF SCAR TISSUE RESULTING IN A CLOSED MANIPULATION. ARTHROFIBROSIS IS A KNOWN POSSIBLE COMPLICATION AFTER SURGICAL INTERVENTION, ALTHOUGH THE SMITH AND NEPHEW DEVICES CANNOT BE EXCLUDED AS TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE EXPLANTED DEVICE WAS REPORTEDLY DESTROYED. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME AND THE PATIENT IMPACT BEYOND THE REPORTED PAIN, INFECTION AND ARTHROFIBROSIS CANNOT BE DETERMINED. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THIS INCLUDED A REVIEW OF STERILIZATION DOCUMENTS WHICH INDICATED THAT THE PRODUCT WAS STERILIZED ACCORDING TO STERILIZATION RELEASE DOCUMENTATION. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO EXCESSIVE LACK OF MOTION, PAIN AND INFECTION. PATELLA WAS NOT REVISED. REPLACED WITH ZIMMER COMPONENTS. EXPLANTS DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311214 JOURNEY TIBIA BASE NP RT SZ 3 PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 16CM0085 03596010554277

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R