MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71421236
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pain (1994)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device indicated in this report is part of a construct.Please refer to mdr 1020279-2017-01233, the master complaint.Other related mdr¿s 1020279-2017-01234, 1020279-2017-01235.
Event or Problem Description
It was reported the patient presented with pain and underwent aspiration of the knee and nerve block ablation in the knee.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: LEGION CR OXIN FEM SZ6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7113394
• Report Number: 1020279-2017-01236
• Device Sequence Number: 13846647
• Product Code: JWH
• UDI-Device Identifier: 00885556030202
• UDI-Public: 00885556030202
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• 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): 03/18/2018

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 Expiration Date: 05/04/2026
• Device Catalogue Number: 71421236
• Device Lot Number: 16EM04536
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/19/2018
• 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: 71420168/16LM09514; 71420576/16MM01226; 71420576/16MM01226
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR