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

Model Number	74022118
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to us through retrospective clinical trial that patient required remedial therapy and other conservative approach due to right knee stiffness.Outcome of this event is unknown and severity was deemed mild.
Additional Manufacturer Narrative
Further inspection of data provided from the clinical site indicated that information reported in follow-up report 1020279-2017-00495-003 are incorrect and for this reason we ask you to disregard this follow-up report.Based on additional information received from the study site this event was re-determined and it was concluded that the reported complaint does not represent an event which requires reporting per cfr 21 part 803.For this reason we ask you to disregard report 1020279-2017-00495.
Additional Manufacturer Narrative
A correction based on new information received.
Event or Problem Description
Remedial thearpy consisted of joint injection / aspiration - 2ml methylprednisolone acetate 80mg and 3.0ml lidocaine 1% plain.

• Brand Name: JRNY BCS II FEMORAL OXIN RT 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: 6688846
• Report Number: 1020279-2017-00495
• Device Sequence Number: 18846498
• Product Code: JWH
• UDI-Device Identifier: 00885556170069
• UDI-Public: 00885556170069
• 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,Followup
• Report Date (Section B): 08/10/2017

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: 05/30/2022
• Device Model Number: 74022118
• Device Catalogue Number: 74022118
• Device Lot Number: 12EM12934
• 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; 07/31/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/17/2017; 08/08/2017; 08/10/2017
• 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 RT SZ 7, 74022217 / UNK LOT; JRNY BCS PAT RESRF RD 41 MM STD, 74024841/UNK LOT; JRNY II BCS XLPEART ISRT (B)(4) 74027273/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 111