MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY II XR KNEE TIB BASEPLATE; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fibrosis (3167)

Event Date 01/18/2022

Event Type  Injury  

Event Description

On the literature review "early outcomes of a novel bicruciate-retaining knee system: a 2-year minimum retrospective cohort study", it was reported that one (1) patient experienced arthrofibrosis after undergoing a bicruciate retaining (bcr) total knee arthroplasty (tka) procedure using a journey ii xr system.The event was treated by performing a tibial revision surgery.Patient's outcome if unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Doi: https://doi.Org/10.1007/s00402-022-04351-2.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the retrospective study identified that 1 patient experienced arthrofibrosis after undergoing a bcr tka and required a tibial revision surgery.As of the date of this medical investigation, the requested clinical documentation has not been provided.However, analysis of the imaging was provided by the articles author(s); therefore, further analysis of the images is not required.Arthrofibrosis is a known possible post-surgical occurrence, and a component malperformance cannot be concluded based on the provided documentation.Without the requested patient specific medical documentation, further clinical factors which could have contributed to the reported event could not be definitively concluded.The patient outcomes beyond that which was reported could not be confirmed nor concluded; therefore, no further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN JOURNEY II XR KNEE TIB BASEPLATE
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15554377
• MDR Text Key: 301335388
• Report Number: 1020279-2022-04357
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKN JOURNEY II CR KNEE FEM COMP; UNKN JOURNEY II XR KNEE TIB INSERT
• Patient Outcome(s): Required Intervention