MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TIB BASE W/JOURNEY LOCK SZ 4 L; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71933570
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	07/30/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was treated with remedial therapy (coumadin 7.5mg po 1x1x4; lovenox 150mg sc 2x1x6) due to deep venous thrombosis , including edema.The event was marked as resolved and mild.
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).

• Brand Name: LEGION TIB BASE W/JOURNEY LOCK SZ 4 L
• 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: 6957317
• Report Number: 1020279-2017-00879
• Device Sequence Number: 1142152
• Product Code: JWH
• UDI-Device Identifier: 00885556170465
• UDI-Public: 00885556170465
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2017

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: 10/25/2019
• Device Catalogue Number: 71933570
• Device Lot Number: 09KM14129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017; 09/21/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 10/18/2017; 12/01/2017
• 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: JOURNEY TIBIA BASE NP LT SZ 5, 74022225/12MM10437; JRNY BCS II FEMORAL OXIN LT SZ6,74022126/13BM11596; JRNY BCS PAT RESRF RD 35MM STD,74024835/13AM08204; JRNY BCS PAT RESRF RD35MM STD,74024835/13AM08204; JRNYIIBCS XLPE ISRT SZ3-4LT18MM,74027247/11JM09908; JRNYIIBCS XLPE ISRT SZ5-6LT9MM,74027261/13BM07555; LGN OFFSET COUPLER 4MM, 71424225/13KSM0245B; LGN PRESSFIT STEM 14MMX160MM,71424047/13HAB0010C; SCR FULL STEP 3-4 10MM, 71423058/13JM18991
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 195