MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT10; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74023262
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery to explant a journey i insert.The insert was found to be broken on x-rays.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The post fractured off the device and was returned.The device was manufactured in 2006 and shows signs of extensive wear.The knee insert post fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.The medical investigation concluded that the two undated, unlabeled x-rays provided show ap and lateral views but are a single time point.It cannot be concluded there is has been shifting of position of the tibia or femoral components to allow for the reported repeated posterior contact to the post.Based on the product evaluation, age related wear was the likely cause of the reported implant breakage.However, we cannot rule out the patient¿s weight, bone quality, trauma history, medical history or change in implant position over time or joint laxity as likely contributing factors to the reported fracture.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.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 was previously identified.Some potential probable causes for this event could include improper sizing or abnormal loading of the limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURN ART INS BCS STD 5-6 LT10
• 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: 9754047
• Report Number: 1020279-2020-00710
• Device Sequence Number: 2611230
• Product Code: JWH
• UDI-Device Identifier: 03596010555212
• UDI-Public: 03596010555212
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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 Expiration Date: 07/28/2016
• Device Model Number: 74023262
• Device Catalogue Number: 74023262
• Device Lot Number: 06GM10753
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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