BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY POLY TIBIAL INSERT

    MDR report key: 6633167 · Received June 12, 2017

    Report

    Report Number
    1020279-2017-00409
    Event Type
    Injury
    Date Received
    June 12, 2017
    Date of Event
    November 16, 2015
    Report Date
    November 22, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2015 DUE TO RECURRENT DISLOCATIONS. DURING THE REVISION, THE INSERT WAS REPLACED. THE PRIMARY RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. PLEASE SEE ATTACHED THE RESULTS OF OUR INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE PROVIDED IS AN ASSUMPTION BASED ON INFORMATION PROVIDED TO US. NO CLEAR DATE OF EVENT WAS COMMUNICATED. REVISION OF CONTRALATERAL KNEE WAS REPORTED THROUGH MDR 1020279-2017-00407.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL ANALYSIS INDICATED THAT THE PATIENT¿S HISTORY AND LONG-TERM CONTINUED USE OF HIGH DOSE OXYCODONE, COMPLEX MEDICAL COMORBID CONDITIONS INCLUDING PERIPHERAL NEUROPATHY, MULTIPLE SCLEROSIS, GENERALIZED WEAKNESSES, MULTIPLE FALLS AND REPORTED NON-COMPLIANCE TO MEDICAL REGIMEN CANNOT BE EXCLUDED AS FACTORS CONTRIBUTING TO THE DISLOCATIONS AND REPORTED REVISIONS. THE SOURCE OF THE JOINT EFFUSIONS, REPORTED PALE YELLOW, GRAY-TAN HARD ARTICULAR BONE AND CARTILAGE AND RUBBERY YELLOW TAN SYNOVIAL TISSUE AND FIBROCARTILAGE OF THE BONE AND TISSUE SAMPLES CANNOT BE CONFIRMED. THE PATIENT IMPACT BEYOND THE REPORTED DISLOCATIONS, REVISIONS, AND CONTINUED PAIN CANNOT BE DETERMINED. WITHOUT THE RETURN OF THE EXPLANTED DEVICES THE EXACT ROOT CAUSE OF THE REPORTED PROSTHETIC FRACTURE CANNOT BE CONCLUDED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PARTS DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCHES. 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    K111711.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED FREQUENT DISLOCATIONS OF THE KNEE AND THAT REVISION SURGERY OCCURED WITH EXCHANGE OF THE TIBIAL POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414161 JOURNEY POLY TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 13LM19620

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization| R 74013480 - 10KNX0001| 74013480 / LOT# 10KNX0001| 74022115 - 14LM09879| 74022115 / LOT# 14LM09879| 74022214 - 14EM21851| 74022214 / LOT# 14EM21851| 74024832 - 13JM04188| 74024832 / LOT# 13JM04188