MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Thrombosis (2100)
Date of Event	04/11/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during implantation there was a surgery complication, patient had a pulmonary embolism/ dvt.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, a pulmonary embolism is a well-known complication/risk of a surgical procedure.However, the information provided is insufficient to determine whether the post-operative pulmonary embolism is due to a pre-existing or concurrent medical condition.Therefore, the exact root cause of the pulmonary embolism cannot be determined at this time.But as a relationship to the procedure in time correlation cannot be excluded and as agreed upon by the surgeon as it has been communicated by the doctor ¿that this is not a product failure but a surgery complication." the patient¿s current medical status has been reported as resolved.No further clinical assessment is warranted at this time based on the information available.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 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 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8051060
• Report Number: 1020279-2018-02417
• Device Sequence Number: 11131151
• Product Code: JWH
• UDI-Device Identifier: 03596010554291
• UDI-Public: 03596010554291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 12/31/2023
• Device Catalogue Number: 74022215
• Device Lot Number: 14AM00431
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 05/07/2019
• 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: Other
• Patient Age: 74 YR