MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022217
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tkr, it was missed that the tibial baseplate was not a genesisii tibial baseplate, but it was journey tibia base np rt sz 7.The item was implanted and when the surgeon attempted to insert the polyethylene tibial insert realized it would not seat.On inspection he realized the tibial error and had to remove it, along with the cement.The correct genesisii tibial baseplate was brought to the room and the procedure continued.The procedure was resumed, after a non-significant delay, using a similar s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).H3,h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the photograph were reviewed, and revealed that the boxes are properly labeled, with clear lettering identifying them as genesis ii and journey implants respectively.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for journey ii¿ bi-cruciate stabilized (bcs) total knee system revealed that revealed in the warnings section that it is the health care professional¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device, and that the instructions must be read completely prior to use.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the label specification, the product was marked as a journey¿ nonporous tibial baseplate.Per inspection drawing the part and configuration must be verified against the print.Device mishandling or misuse such as implanting the incorrect baseplate due to not checking the label/having labeling problems are documented within the complaint management system to facilitate failure monitoring and trending.Based on the nature of the failure reported and the low risk of the complaint, no further investigation is required nor updates to instruction for use and surgical technique.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error.Based on this investigation, the need for corrective action is not indicated.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: JOURNEY TIBIA BASE NP RT SZ 7
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23919209
• Report Number: 1020279-2025-02139
• Device Sequence Number: 15659586
• Product Code: JWH
• UDI-Device Identifier: 03596010554390
• UDI-Public: 3596010554390
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74022217
• Device Lot Number: 25BM06393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown