MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74027232
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/26/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a manipulation under anesthesia due to loss of flexion.
Event or Problem Description
Additional information indicates the patient was readmitted (b)(6) 2015 due to manipulation under anesthesia.The patient also presented with swelling of the right knee on (b)(6) 2016 however no treatment was provided.
Additional Manufacturer Narrative
Other components involved in this event, as outlined in d11, have been communicated through mdrs 1020279-2017-01140 , 1020279-2017-01142 and 1020279-2017-01143.(b)(4).

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7069967
• Report Number: 1020279-2017-01141
• Device Sequence Number: 1119020
• Product Code: JWH
• UDI-Device Identifier: 00885556179062
• UDI-Public: 00885556179062
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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: 07/30/2022
• Device Catalogue Number: 74027232
• Device Lot Number: 12HM00332
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017; 10/30/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/08/2017; 02/22/2018
• 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: 71421032/14LM02471; 74022115/14LM06963; 74022214/14JM03460
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 77