MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 RT 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027238
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Foreign Body In Patient (2687)
Date of Event	09/06/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a clinical study that the patient had been revised due to a popping sound in the right knee.Intraoperatively the surgeon came across a piece of bone about the size of end of pinkie which was removed as well as did debridement of posterior capsular scar tissue which may have contributed to popping sound.Tibial liner has been replaced but was noted that the liner was well fixed and had not dislodged.
Additional Manufacturer Narrative
Correction based on new information received.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 RT 21MM
• 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: 6456608
• Report Number: 1020279-2017-00239
• Device Sequence Number: 10916174
• Product Code: JWH
• UDI-Device Identifier: 00885556194935
• UDI-Public: 00885556194935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/13/2017

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: 12/11/2021
• Device Catalogue Number: 74027238
• Device Lot Number: 11MM08447
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided; 07/22/2017; 07/22/2017
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 04/25/2017; 07/25/2017; 09/13/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 81