MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 6N RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71423226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the dr did a 1st stage revision on patient.The indication for the removal of implants was infection.Dr said that the patient had a cut/skin injury to her leg since (b)(6) 2017, which did not heal properly.Consequent infection of the joint followed as the patient is a diabetic.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.Please see attached file for our results of investigation.(b)(4).

• Brand Name: LEGION NARROW PS OXIN SZ 6N RT
• 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: 6621980
• Report Number: 1020279-2017-00401
• Device Sequence Number: 760303
• Product Code: JWH
• UDI-Device Identifier: 03596010611413
• UDI-Public: 03596010611413
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2017

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: 01/26/2026
• Device Model Number: 71423226
• Device Catalogue Number: 71421276
• Device Lot Number: 16AM19476
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 05/12/2017; 05/12/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/02/2017; 11/23/2017
• 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: 71420166 / 16HM00257, GNS II CMT TIB SIZE 4 LEFT; 71420576 / 16AM00626, GNS II RESURF PAT 32MM; 71421508 / 16AM06720, GII PS HI FLEX ISRT SZ 3-4 9
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 84