MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025623
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Crepitus (4893)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, in a clinical study, after a left tka was performed on (b)(6) 2016, the patient experienced a medial and lateral left knee pain and instability following trauma to anterior knee.A revision surgery was performed on (b)(6) 2025, in which the jrny ii cr isrt xlpe lt sz 1-2 11mm was explanted and was noticed broken in the posteromedial side.The current health status of the patient is unknown.
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 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 alter the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device finds the journey insert significantly damaged and discolored with notable material loss to one side, leaving sharp edges and deformation.The clinical/medical investigation concluded that, the likely clinical root cause is the traumatic impact to the anterior knee, which reportedly caused the immediate onset of medial and lateral left knee pain, instability, swelling, and clicking, consistent with a broken post and warranting revision.Intraoperative findings confirmed global laxity and revealed a fractured posteromedial aspect of the polyethylene insert, while all components were well-fixed and in excellent position, with only minimal scratching on the femoral component and a negative infection work-up.It remains unknown whether the time between the injury in april 2025 and the revision in september 2025, and/or ambulation with a potentially deformed articulating insert, contributed to the observed damage.The patient impact included immediate symptoms following trauma and the need for revision surgery, with an anticipated transient restorative phase postoperatively; the patient was reportedly doing well after the procedure.It cannot be determined if the minimal scratching on the femoral component will adversely affect the long-term outcome.The instructions for use warns that implants have a finite service life and may fail due to strenuous activity or trauma, which aligns with the circumstances of this case.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 knee systems, and revealed that the implant can break or become damaged as a result of strenuous activity or trauma.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 with material specifications, the quality and manufacture of 7.5 mrad cross-linked ultra-high molecular-weight polyethylene bar stock shall be controlled.These materials are used in the manufacture of surgical implants and instruments, and can be considered a surgical grade of uhmwpe and cross-linked polyethylene.Also, per inspection drawing, the final inspection includes the verification of part configuration per print.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 excessive forces and/or injury.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 CR ISRT XLPE LT SZ 1-2 11MM
• 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: 23450985
• Report Number: 1020279-2025-01820
• Device Sequence Number: 8057101
• Product Code: JWH
• UDI-Device Identifier: 00885556422656
• UDI-Public: 885556422656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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 Expiration Date: 09/01/2025
• Device Catalogue Number: 74025623
• Device Lot Number: 15JM03968
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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: 71932636/GEN II 7.5MM RESUR PAT 32MM.; 74021164/JRNY II CR FEM OX NP LT SZ 4.; 74022222/JOURNEY TIBIA BASE NP LT SZ 2.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female