MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 7; PROSTH, KNEE, PATELLOFEMORTIBIAL, SEMICONSTRAINED, CMNTD

Catalog Number	74022117
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	10/31/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee aspiration.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for investigation results.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 7
• Common Device Name: PROSTH, KNEE, PATELLOFEMORTIBIAL, SEMICONSTRAINED, CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6860423
• Report Number: 1020279-2017-00736
• Device Sequence Number: 13595864
• Product Code: JWH
• UDI-Device Identifier: 00885556170014
• UDI-Public: 00885556170014
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2017

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: 04/16/2023
• Device Catalogue Number: 74022117
• Device Lot Number: 13DM13433
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017; 08/21/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 09/28/2017; 11/15/2017
• 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: 59 YR
• Patient Weight: 53