MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT10; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an insert failure, the post was broken.The physician needed to replace the liner with a new revision journey insert.The item number and lot number can not be read on original insert due to wear.The original surgery was around 11 years ago.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that a revision surgery was performed due to an insert failure, the post was broken.The physician needed to replace the liner with a new revision journey insert so a journey revision insert trial with bigger post was used to fix the issue.The original surgery was around 11 years ago.There was no delay in revision.The outcome of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.The lab analysis concluded the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The articulating and non-articulating surfaces of the insert are worn with some discoloration.The post is bent, and the tip 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 per complaint details, a revision was performed approximately 11 years post implantation due to post breakage.Reportedly, the "patient had no specific activity that caused insert to break".The requested op-notes and radiological imaging were not provided for inclusion in the medical investigation.Based on the information provided, the root cause of the reported post breakage could not be concluded and the patient impact beyond the reported event and subsequent revision could not be determined.The current patient status remains unknown.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.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 3-4 RT10
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10590023
• Report Number: 1020279-2020-04877
• Device Sequence Number: 16901201
• Product Code: JWH
• UDI-Device Identifier: 03596010555007
• UDI-Public: 03596010555007
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: No
• Operator of Device: Health Professional
• Device Model Number: 74023232
• Device Catalogue Number: 74023232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 09/02/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/03/2020; 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