MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that according to the swiss national hip & knee joint registry annual report, about hip and knee replacement results between 2012 ¿2019 it was found that the following complications/harms occurred: 5 patients with journey ii bcs knee fem comp suffer of joint stiffness/arthrofibrosis.No more information available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the swiss national hip & knee joint registry annual report, indicates that 5 patients underwent a journey ii bcs revision surgery due to joint stiffness/arthrofibrosis.Based on the information provided, the clinical root cause and/or patient outcome beyond that which is documented in the report cannot be definitively concluded.No further medical assessment can be rendered at this time.Some potential probable causes could be alignment, fit/size of device used or wear.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11130716
• MDR Text Key: 225496054
• Report Number: 1020279-2021-00180
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention