MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMNTD,POLYMER/METAL

Model Number	74022206
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); Joint Disorder (2373)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the jrny ii xr baseplate sz 6 lt was removed in a revision surgery on (b)(6) 2020 due to patient instability.A journey primary tibia with retaining insert was implanted in revision surgery.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that approximately a year and a half post implantation, the jii baseplate was revised to a journey primary tibia with retaining insert, due to instability.To date, the requested surgical reports and x-rays have not been provided.Therefore, due to limited information, no further assessment can be performed at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to fit/sizing issue, lifetime of device or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: JRNY II XR BASEPLATE SZ 6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMNTD,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10474877
• Report Number: 1020279-2020-04323
• Device Sequence Number: 3218688
• Product Code: JWH
• UDI-Device Identifier: 00885556615362
• UDI-Public: 00885556615362
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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 Expiration Date: 06/26/2026
• Device Model Number: 74022206
• Device Catalogue Number: 74022206
• Device Lot Number: 16FSL0006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 06/30/2021
• 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