MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	74027261
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery in which the poly insert was exchange.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history on the listed parts revealed no prior complaints for the listed batch.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Products were sterilized according to sterilization release documentation from quality control.Our clinical evaluation noted that based on the available information, the cause of this revision of the poly insert was, as documented the infection and not device related.No information on the patient¿s current status was provided at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6921442
• Report Number: 1020279-2017-00829
• Device Sequence Number: 13626214
• Product Code: JWH
• UDI-Device Identifier: 00885556177969
• UDI-Public: 00885556177969
• 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: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/17/2018

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: No Information
• Device Expiration Date: 12/25/2023
• Device Catalogue Number: 74027261
• Device Lot Number: 13MM17688
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017; 09/14/2017; 09/14/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/17/2017; 05/02/2018; 05/17/2018
• 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: FEMORAL PART: 74022126 / LOT: UNKNOWN; PATELLA PART: 74024623 / LOT: UNKNOWN; TIBIA BASE PART: 74022225 / LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 170