MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM COCR NP LT SZ 5; PROSTH, KNEE, PATELLFEMTIBIAL, SEMI-CONSTR, CEMENTED, POLY/METAL/POLY

Model Number	74021265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fever (1858)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery had been performed with a jrny ii cr isrt xlpe lt sz 3 4 10mm, jrny ii cr fem cocr np lt sz 5 and the journey tibia base np lt sz 4, the clinical subject experienced post op fever and had to be hospitalized.This adverse event was treated with medication and it was resolved.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per the complaint details, the patient required hospitalization for a post-op fever.The provided clinical record forms revealed that the patient experienced a moderate post-op fever 2 days post-tka ((b)(6) 2019) which was documented as definitely related to the study device and surgery; however, the fever resolved the next day with an end date of (b)(6) 2019.The provided clinical record forms did not provide insight into the root cause of the reported fever or hospitalization course/treatment.The patient impact beyond the reported fever which resolved the day after hospitalization could not be determined.The ae was documented as resolved.No further medical investigation is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Possible causes could include but not limited to patient reaction.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: JRNY II CR FEM COCR NP LT SZ 5
• Common Device Name: PROSTH, KNEE, PATELLFEMTIBIAL, SEMI-CONSTR, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11862818
• Report Number: 1020279-2021-04575
• Device Sequence Number: 1009009
• Product Code: JWH
• UDI-Device Identifier: 00885556615263
• UDI-Public: 00885556615263
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 74021265
• Device Catalogue Number: 74021265
• Device Lot Number: B1810604R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022224JOURNEY TIBIA BASE NP LT SZ 4; 74025642JRNY II CR ISRT XLPE LT SZ 3-4 10MM; 74022224JOURNEY TIBIA BASE NP LT SZ 4; 74025642JRNY II CR ISRT XLPE LT SZ 3-4 10MM
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention