MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM; PRSTHSIS,KNEE,PATELLOFMOROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMER/METAL/POLYMER

Catalog Number 74027241

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/28/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to hematoma.Arresting of bleeding and synovectomy were performed.Insert was replaced to 10mm insert.

Manufacturer Narrative

The associated journey ii bcs articular insert was not returned for evaluation.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of product information.A clinical evaluation noted that no clinical relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, a trauma as a contributing factor to the revision based on the complaint of a poly revision approximately 4 years post implantation in a 90 year old male due to a hematoma and bleeding could not be ruled out.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.We will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, unable to rule out trauma as a contributing factor to the revision based on the complaint of a poly revision approximately 4 years post implantation in a 90 year old male due to a hematoma and bleeding.The patient impact beyond the unknown precursor to the hematoma/bleeding, the poly exchange and an expected post-op rehabilitation phase cannot be determined.No further medical assessment is warranted at this time.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM
• Type of Device: PRSTHSIS,KNEE,PATELLOFMOROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8206878
• MDR Text Key: 131734592
• Report Number: 1020279-2018-02956
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556177617
• UDI-Public: 00885556177617
• Combination Product (y/n): N
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74027241
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 90 YR