MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT BICONVEX 26 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74024626
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent arthroscopical removal of patellar component due to its loosening.
Additional Manufacturer Narrative
Correction based on new information received.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: JRNY BCS PAT BICONVEX 26 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6847582
• Report Number: 1020279-2017-00714
• Device Sequence Number: 1600200
• Product Code: JWH
• UDI-Device Identifier: 03596010554475
• UDI-Public: 03596010554475
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2017

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: 05/21/2023
• Device Catalogue Number: 74024626
• Device Lot Number: 13EM16200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/08/2017; 09/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/26/2017; 10/26/2017
• 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: 60 YR
• Patient Weight: 125