MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 LT 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74029246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a revision surgery was performed due to unspecified reasons.The original plan was a full revision of journey ii knee but intraoperative changed plan to leave the journey ii bcs femur and use a legion-journey lock detail revision tibia with a j2 bcs constrained insert.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, based on the limited information provided, the root cause of the reported revision and the ¿inadvertently coupled¿ knee components could not be definitively concluded.Patient impact beyond the reported event could not be assessed; therefore, no further medical assessment can be rendered 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 review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no probable cause can be delineated.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.Additional information: d3.

• Brand Name: JRNY II BCS CNSTRD ART ISRT 3-4 LT 15M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12953559
• Report Number: 1020279-2021-08549
• Device Sequence Number: 4790015
• Product Code: JWH
• UDI-Device Identifier: 00885556176269
• UDI-Public: 00885556176269
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 04/21/2024
• Device Model Number: 74029246
• Device Catalogue Number: 74029246
• Device Lot Number: 14DM18155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown