MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a right tka performed on (b)(6) 2023, the patient presented an infected knee joint approximately 3-4 weeks post operatively; so a 2-stage revision surgery had to be programmed.The first stage was performed on (b)(6) 2023, where the primary jrny ii implants (jrny ii bcs femoral oxin rt sz 6, jrny ii bcs xlpe art isrt sz 5-6 rt 10mm, journey tibia base np rt sz 6, gii oval resurfacing pat 35mm) had to be removed, and an articulating cement spacer with antibiotic was implanted.Second stage revision surgery was planned with in a period of 12 weeks, providing infection settled down.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that as of the date of this medical investigation, no supporting clinical documentation has been provided; therefore, the source of the reported infection cannot be definitively concluded.Patient impact beyond the reported infection and staged revision cannot be determined.The patient¿s current health status is unknown.No further medical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents knee systems revealed that acute post-surgical wound infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: JRNY II BCS FEMORAL OXIN RT SZ 6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 16690311
• Report Number: 1020279-2023-00769
• Device Sequence Number: 20673278
• Product Code: JWH
• UDI-Device Identifier: 00885556169964
• UDI-Public: 00885556169964
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: 74022116
• Device Catalogue Number: 74022116
• Device Lot Number: 22EM00180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/09/2023
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULATING CEMENT SPACER WITH ANTIBIOTIC, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown