MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 4; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a study that the patient had cellulitis as a result of lymphangitis over the anterolateral aspect of the proximal tibia.The knee was reported as warm and hypersensitive; patient admitted to hospital for iv antibiotic regime to treat.The event was assessed by the reporter as related to the study procedure and the possibility of the device causing or contributing to the event could not be excluded.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without the requested clinical information, radiographs, lab reports, operative report or the explant, the root cause of the report cellulitis cannot be concluded but cellulitis is a complication of the implant procedure and not due to contamination of the component itself.Since this issue has resolved no further harm to this patient is anticipated.No further clinical/medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the time.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 4
• 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: 8457057
• Report Number: 1020279-2019-01221
• Device Sequence Number: 429233
• Product Code: JWH
• UDI-Device Identifier: 03596010554284
• UDI-Public: 03596010554284
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 07/14/2023
• Device Catalogue Number: 74022214
• Device Lot Number: 13GM10560
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 85