MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74022129
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); Joint Disorder (2373)
Date of Event	10/21/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had revision surgery due to mechanical loosening on the left knee.For that reason patient underwent remedial therapy (durg/transfusion) and surgical procedure.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached for investigation results.(b)(4).

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6823351
• Report Number: 1020279-2017-00663
• Device Sequence Number: 13573877
• Product Code: JWH
• UDI-Device Identifier: 00885556170618
• UDI-Public: 00885556170618
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2017

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: 05/18/2023
• Device Catalogue Number: 74022129
• Device Lot Number: 13EM12911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/28/2017; 08/28/2017; 08/28/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 08/31/2017; 08/31/2017; 10/10/2017
• 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 LT SZ 7, (B)(4); JRNY BCS PAT BICONVEX 26 MM STD, (B)(4); JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 86