MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 6; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	74022216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient suffered from dermatitis since two weeks after the knee replacement on both legs.Patient is willing to obtain a metal allergy test (melisa testing) from a medical institute in (b)(6).Patient has received multiple dupixent injections, once every two weeks since (b)(6) 2017 for rash and itching.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that the root cause of the reported dermatitis cannot be determined.The information provided insufficient to determine whether the patient's symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.The future impact to the patient is unknown.No further clinical/medical assessment can be rendered at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batches with this failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 6
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7519645
• Report Number: 1020279-2018-00940
• Device Sequence Number: 13759252
• Product Code: JWH
• UDI-Device Identifier: 03596010554307
• UDI-Public: 03596010554307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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 Catalogue Number: 74022216
• Device Lot Number: 17DM00909
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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: 71210003/16KSM0363
• Outcome Attributed to Adverse Event: Other