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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	01/12/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
Event or Problem Description
It was reported a surgical procedure occurred for manipulation of left knee due to stiffening.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.(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: 6691479
• Report Number: 1020279-2017-00500
• Device Sequence Number: 16154698
• Product Code: JWH
• UDI-Device Identifier: 00885556170564
• UDI-Public: 00885556170564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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 Model Number: 74022128
• Device Catalogue Number: 74022128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 10/23/2017
• 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: 58 YR
• Patient Weight: 102