MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023283
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a journey i total knee system was put into patient on (b)(6) 2007.Patient recently came to surgeon complaining of ¿clicking¿ noise.Surgeon scheduled poly exchange.Upon incision, it was found that the post on the articular insert had broken off.No more information was provided yet.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported articular insert break and clicking noise cannot be determined.Failure of implant malfunction of a medical implant.Additional surgery surgical intervention that was not planned and needed to be performed in addition to other interventions including surgical ones.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURN ART INS BCS STD 7-8 LT11
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8834700
• Report Number: 1020279-2019-02816
• Device Sequence Number: 13509690
• Product Code: JWH
• UDI-Device Identifier: 03596010555366
• UDI-Public: 03596010555366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 74023283
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/28/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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