MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 5; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022225
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized due to pulmonary embolism.And treated with an unknown remedial therapy.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, insufficient clinically relevant documentation was provided; therefore, a through medical investigation could not be performed.However, per clinical report forms (crf), the patient experienced a pulmonary embolism (sae#2) following a surgical procedure for a sbo (sae#1) approximately 6 weeks post left tka.Based on the crf, the device and/or procedure could not be ruled out as a possible contributing factor to the pe.The pulmonary embolus event was reportedly resolved after remedial therapy and hospitalization.No further patient impact is anticipated and no further 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.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 5
• 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: 8867775
• Report Number: 1020279-2019-02945
• Device Sequence Number: 19518555
• Product Code: JWH
• UDI-Device Identifier: 03596010554338
• UDI-Public: 03596010554338
• Combination Product (Y/N): N
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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 Catalogue Number: 74022225
• Device Lot Number: 17JM04245
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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