MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 4; PRSTHSIS,KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	74022114
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/16/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was hospitalized due to wound bleeding.
Event or Problem Description
It was reported that patient was hospitalized due to blood pressure dropped.
Additional Manufacturer Narrative
The associated journey ii bcs femoral oxinium, journey ii bcs articular insert, journey tibial baseplate and journey bcs resurfacing patella were not returned for evaluation.A clinical analysis noted that several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.As batch numbers were not made available, device history record review cannot be completed at this time.Complaint history review could not be performed with any accuracy due to lack of the lot number.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.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 re-opened.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 4
• Common Device Name: PRSTHSIS,KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7521864
• Report Number: 1020279-2018-00951
• Device Sequence Number: 19138725
• Product Code: JWH
• UDI-Device Identifier: 00885556169865
• UDI-Public: 00885556169865
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2019

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 Catalogue Number: 74022114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 08/28/2017; 08/28/2017
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 09/05/2018; 04/29/2019
• 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: 74022213 - UNKNOWN; 74024832 - UNKNOWN; 74027231 -UNKNOWN; 74022213 - UNKNOWN; 74024832 - UNKNOWN; 74027231 -UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 59 YR