MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144); Fluid Discharge (2686); Blister (4537)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2023, the patient experienced significant vomit and nausea (from oxycodone-pca) and mild wound-ooze at day 1 post operation with two small blisters.Discharge on (b)(6) 2023.Later, patient was re-admitted on (b)(6) 2023 for wound-ooze observations and discharge on (b)(6) 2023 after no wound-ooze for past 24 hours.No changes to medication.Patient is recovering.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
Although the involvement of all the devices was reported, with the information provided it is not possible to relate investigated failure with the implants.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without patient-specific clinical information, a thorough medical investigation cannot be rendered nor could the definitive clinical root cause of the reported adverse events be determined.Of note the patient¿s oxycodone was discontinued and changed to a stronger medication and the was patient discharged with no signs of infection or wound dehiscence.Based on the limited information provided, the patient is recovering.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that healing issues has been identified in possible adverse effects.A review of the risk management file 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 product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.Based on this investigation, the need for corrective action is not indicated.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: JRNY II BCS FEMORAL OXIN LT SZ 5
• 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: 17785464
• Report Number: 1020279-2023-01809
• Device Sequence Number: 20552009
• Product Code: JWH
• UDI-Device Identifier: 00885556170410
• UDI-Public: 00885556170410
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: Lay User/Patient
• Device Catalogue Number: 74022125
• Device Lot Number: 22LM01141
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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: 71420576/GNS II RESURF PAT 32MM; 74022225/JOURNEY TIBIA BASE NP LT SZ 5; 74027261/JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; STOPPED THE OXYCODONE, STARTED CLEXANE (B)(6) 2023
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 107 KG