MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022225
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
Event or Problem Description
Revision of tibia component was performed due to loosening.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 5
• 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: 6527083
• Report Number: 1020279-2017-00301
• Device Sequence Number: 1457889
• Product Code: JWH
• UDI-Device Identifier: 03596010554338
• UDI-Public: 03596010554338
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: 01/15/2022
• Device Catalogue Number: 74022225
• Device Lot Number: 10KM13654B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: 74023262/08GM03920, JOURNEY ARTICULAR INSERT BCS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR