MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM SIZING GDE LT; PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	74012455
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the journey ii tka fem sizing gde left is not staying on 3 degree mark.Problem was noticed during a case.No injury to the patient or surgical delay was reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection shows signs of wear and tear.A functional evaluation of the returned device confirmed the stated failure mode.The size adjuster on the device is damaged and loose, rendering it inoperable.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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: JRNY II TKA FEM SIZING GDE LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11240732
• Report Number: 1020279-2021-00692
• Device Sequence Number: 4061974
• Product Code: JWH
• UDI-Device Identifier: 03596010672087
• UDI-Public: 03596010672087
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74012455
• Device Catalogue Number: 74012455
• Device Lot Number: 12ABG0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1