MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	74022205
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the revision surgery was performed due to loose baseplate.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.Please see attached the results of our investigation.(b)(4).

• Brand Name: JRNY II XR BASEPLATE SZ 5 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6857877
• Report Number: 1020279-2017-00732
• Device Sequence Number: 19032689
• Product Code: JWH
• UDI-Device Identifier: 00885556615355
• UDI-Public: (01)00885556615355(17)260615(10)16FSL0002
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: 06/15/2026
• Device Model Number: 74022205
• Device Catalogue Number: 74022205
• Device Lot Number: 16FSL0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74023762/16BM12245; 74023862/16EM10888
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR