MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74023253
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was sitting on a chair and upon rising he felt that the knee became unstable.Upon inspecting the patient intraoperatively it was discovered that the insert was fractured.A revision surgery was performed to implant a new insert.
Additional Manufacturer Narrative
It was reported that the patient was sitting on a chair and upon rising he felt that the knee became unstable.Upon inspecting the patient intraoperatively it was discovered that the insert was fractured.The affected journey bcs articular insert, used in treatment, was not returned for evaluation.However, photos were provided which confirmed the stated failure.The peg has broken off of the insert.As device information was not made available, device history record cannot be completed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to traumatic injury, size of device or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURN ART INS BCS STD 5-6 RT11
• 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: 9187480
• Report Number: 1020279-2019-03651
• Device Sequence Number: 2413804
• Product Code: JWH
• UDI-Device Identifier: 03596010555151
• UDI-Public: 03596010555151
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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 Model Number: 74023253
• Device Catalogue Number: 74023253
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 03/13/2020
• 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