MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT10; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL

Model Number	74023252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a journey art insert bcs standard 5-6 right10 implanted around 10 years ago and a revision surgery was performed due to the patient was complaining of discomfort and instability.When going to remove the journey art insert bcs standard 5-6 right10, it was noticed that the insert's post had been sheared off.The broken insert was removed and replaced by a new implant.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The articulating and nonarticulating surfaces of the insert are worn with some discoloration.The post was fractured off of the insert.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical/medical evaluation concluded that this complaint from the united states reports that the post on a journey ii insert broke after about 10 years insitu.No report of trauma or accident was provided.The broken implant has been removed and replaced by a new.Impact to the patient beyond the pain, revision surgery and recovery cannot be determined.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 RT10
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10451301
• Report Number: 1020279-2020-04197
• Device Sequence Number: 4030863
• Product Code: JWH
• UDI-Device Identifier: 03596010555144
• UDI-Public: 03596010555144
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2018
• Device Model Number: 74023252
• Device Catalogue Number: 74023252
• Device Lot Number: 08HM00881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/02/2021
• 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