MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 6; PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMTALPOLYMR

Model Number	74022126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia was performed due to an arthrofibrosis.
Additional Manufacturer Narrative
The devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2015 and 2016.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: the root cause of the medical intervention (whether an arthroscopy and/or mua) was the reported arthrofibrosis which is a known potential complication post surgical trauma and does not indicate or support a malfunction or failure of the device.The patient impact beyond the reported symptoms and subsequent intervention could not be determined as the patient did not follow-up.No further medical assessment can be rendered at this time.A root cause could not be determined at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 6
• Common Device Name: PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMTALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9711194
• Report Number: 1020279-2020-00545
• Device Sequence Number: 2500373
• Product Code: JWH
• UDI-Device Identifier: 00885556170465
• UDI-Public: 00885556170465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 02/01/2026
• Device Model Number: 74022126
• Device Catalogue Number: 74022126
• Device Lot Number: 16BM04053
• Initial Date Received by Manufacturer: 02/02/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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