MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UK MED TIB BASE SZ 8 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74026728
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference (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 inherent device and/or procedural risks 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.
Event or Problem Description
It was reported that, following a right tka where a journey ii uk tib insrt med sz 7-8 8mm was implanted, the patient began experiencing pain, developed a limp, and suspects the implant may be loose.The patient is currently awaiting device removal; revision surgery will be performed on (b)(6) 2025.No additional clinical details or outcomes were reported.
Additional Manufacturer Narrative
Additional information: b6, b7.Corrected data: b3, b5, d1, d4 (catalog number, lot number, expiration date, unique identifier (udi) #), d10, h4, h6 (health effect - clinical code, health effect - impact code).
Event or Problem Description
It was reported that, after a right uka was performed, the patient began experiencing pain, developed a limp, and suspects the implant may be loose.Imaging reports confirmed the loosening of the journey ii uk med tib base sz 8 rt.The patient is currently awaiting device removal; revision surgery will be performed on 18-aug-2025.No additional clinical details or outcomes were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, findings of the (b)(6) 2025 computed tomography right knee without contrast include: subsidence of tibial tray with associated lucency suggestive of loosening."patellofemoral" and lateral tibial compartment loss of joint space, osteophytes, multiple-intra-articular loose bodies (up to 5mm) and ossific density within the distal patellar tendon which is thickened.The clinical root cause of the subsidence and loosening about the tibial tray noted on computed tomography cannot be definitively concluded; however, the component selection, positioning and fixation along with the patient¿s body mass index cannot be ruled out as potential contributing factors to the component subsidence/loosening and reported patient symptoms.The time between symptom onset and the scheduled revision could directly impact the severity of symptoms.The patient impact beyond the reported symptoms, interventions (diagnostics, medication and assist devices) and scheduled revision cannot be determined with certainty as the procedure has yet to be performed as of the date of this medical investigation.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers 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 revealed that "unicompartmental" knee systems revealed in adverse reactions that looseness of components can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/ or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Besides, adverse reactions section also states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, inadequate integration between the cement and bone/implant, osteolysis and/or injury.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 II UK MED TIB BASE SZ 8 RT
• 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: 22561118
• Report Number: 1020279-2025-01255
• Device Sequence Number: 9566342
• Product Code: HSX
• UDI-Device Identifier: 00885556682227
• UDI-Public: 00885556682227
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 74026728
• Device Lot Number: 21CAP0034
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 10/15/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/19/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: 74026038 LN: 24CM01220. JOURNEY II UK OX FEM S.; PN: 74026038 LN: 24CM01220. JOURNEY II UK OX FEM S.; PN: 74026178 LN: 22EAP0123J. JOURNEY II UK TIB INS.; PN: 74026728 LN: 21CAP0034. JOURNEY II UK MED TIB.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 145 KG