MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022128
Health Effect - Clinical Codes	Muscular Rigidity (1968); Swelling (2091)
Date of Event	07/01/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through retrospective clinical trial that patient required remedial therapy and other conservative approach in order to solve left knee stiffness and swelling.Outcome of this event has been reported as resolved with residual effects on (b)(6) 2014 and severity was deemed as mild.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.(b)(4).

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 8
• 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: 6686268
• Report Number: 1020279-2017-00491
• Device Sequence Number: 2066019
• Product Code: JWH
• UDI-Device Identifier: 00885556170564
• UDI-Public: 00885556170564
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2017

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: 04/02/2022
• Device Model Number: 74022128
• Device Catalogue Number: 74022128
• Device Lot Number: 12DM10458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/16/2017; 07/31/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 07/17/2017; 08/11/2017
• 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 6, 74022226/UNK LOT; JRNY BCS PAT RESRF RD 41 MM STD, 74024841/UNK LOT; JRNY II BCS XLPE ARTISRT SZ5-6LT9MM, 74027261/UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 94