MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022125
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through retrospective clinical trial that patient underwent other conservative approach procedure in order to solve post tka arthrofibrosis of the left knee.Event was resolved on (b)(6) 2012 and its severity was deemed to be mild.
Additional Manufacturer Narrative
Correction based on new data received.
Additional Manufacturer Narrative
Based on additional information received from the study site, which contained corrections to previously reported data, 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 1020279-2017-00509.
Additional Manufacturer Narrative
Based on additional information received from the study site, which contained corrections to previously reported data, 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 1020279-2017-00509.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 5
• 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: 6693279
• Report Number: 1020279-2017-00509
• Device Sequence Number: 19052724
• Product Code: JWH
• UDI-Device Identifier: 00885556170410
• UDI-Public: 00885556170410
• 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,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2017

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: No Information
• Device Model Number: 74022125
• Device Catalogue Number: 74022125
• Device Lot Number: 12AM18836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017; 06/08/2017; 06/08/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/08/2017; 08/11/2017; 09/18/2017
• 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 3, (B)(4)/UNK LOT; JRNY BCS PAT RESRF RD 35 MM STD, (B)(4)/UNK LOT; JRNY II BCS XLPE ARTISRT SZ3-4LT10MM, 74027242/UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 93