MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY BCS / JOURNEY II BCS KNEE; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Thromboembolism (2654); Unspecified Heart Problem (4454); Insufficient Information (4580)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Singh, v., yeroushalmi, d., christensen, t.H., bieganowski, t., tang, a., & schwarzkopf, r.(2022).Early outcomes of a novel bicruciate-retaining knee system: a 2-year minimum retrospective cohort study.Archives of orthopaedic and trauma surgery, 1-7.Doi: 10.1007/s00402-022-04351-2.

Event Description

It was reported that on literature review "early outcomes of a novel bicruciate-retaining knee system: a 2-year minimum retrospective cohort study" 1 patient had a intraoperative complication medial tibial plateau fracture resulted in orif and was treated with a subsequent removal of fixation hardware and 4 patients required a reoperation (of which 1 had a tibial revision to a conventional cr tka secondary to acl tear and 1 had a tibial revision for arthrofibrosis and) after a bicruciate retaining total knee arthrosplasty where a journey¿ ii xr¿ bi-cruciate retaining knee system were received using a journey ii bcs knee tibial component.2 patients had a tibial poly liner exchange due to infection and a arthrofibrosis after a bicruciate retaining total knee arthrosplasty where a journey¿ ii xr¿ bi-cruciate retaining knee system were received using a journey ii bcs knee poly liner component.2 patients required a full revision due to infections and arthrofibrosis after a bicruciate retaining total knee arthrosplasty, also 1 patient required a ed visit in the first 90 days after surgery due to venous thromboembolism (vte) and 1 patient was readmitted after surgery in the first 90 days due to a cardiac complication where a journey¿ ii xr¿ bi-cruciate retaining knee system were received, using a journey ii bcs knee fem comp.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the root cause of the reported symptoms and events cannot be definitively concluded and the impact beyond the reported cannot be determined.The individual patients¿ current health status was not provided as requested.Therefore, no further patient medical assessment can be rendered.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection, procedural/user error, surgical complication, patient medical history 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 BCS / JOURNEY II BCS KNEE
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: 13510701
• MDR Text Key: 288381200
• Report Number: 1020279-2022-00652
• Device Sequence Number: 1
• Product Code: JDH
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• 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
• Patient Outcome(s): Other; Required Intervention; Hospitalization