MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74022213
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed cellulitis in the right lower extremity.The event was treated via medication and medical intervention to prevent a life-threatening condition in the subject.
Additional Manufacturer Narrative
H10: the devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2015 and 2016.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Product was sterilized according to sterilization release documentation from quality control.Our clinical/medical team noted: without the requested relevant clinical information, the reported cellulitis cannot be confirmed.However, per communications, this event resolved with medication and a life saving intervention.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.At this time a definitive root cause could not be determined.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 3
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9842156
• Report Number: 1020279-2020-00906
• Device Sequence Number: 16325622
• Product Code: JWH
• UDI-Device Identifier: 03596010554277
• UDI-Public: 03596010554277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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 Expiration Date: 03/01/2026
• Device Model Number: 74022213
• Device Catalogue Number: 74022213
• Device Lot Number: 16AM03018
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention