MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422255
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a ukr surgery, a journey uni tibinrt s3-4rm/ll8mm was not getting locked properly.The surgeon tried another journey uni tibinrt s3-4rm/ll9mm, however, it also failed to lock at the final stage.Due to this issue, the surgeon had no option but to remove both the femoral and tibial components, and the procedure was converted to a total knee replacement (tkr) instead of the planned unicondylar knee replacement (ukr).Procedure was performed after a greater than 30 min delay.No additional anesthesia was required.The patient's current state of health is fine.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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.

• Brand Name: JOURNEY UNI TIBINRT S3-4RM/LL8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 24310487
• Report Number: 1020279-2026-00196
• Device Sequence Number: 5583442
• Product Code: HSX
• UDI-Device Identifier: 03596010582164
• UDI-Public: 3596010582164
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K230653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 71422255
• Device Lot Number: 24CM03359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71422355, LN:24EM05426; PN: 71422434,LN:24EM12555; PN:71422256,LN: 22LM09841
• Patient Age: 69 YR
• Patient Sex: Female