MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR LOCK FEM IMPLANT IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74011711
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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 conservatively 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, during a tka surgery, when implanting the (1) jrny ii cr isrt xlpe rt sz 5-6 9mm and the (1) jrny ii cr fem ox np rt sz 6, the handle of one (1) jrny ii cr lock fem implant impactor seized up, not being able to release the implant from the device.A bcs femur was implanted instead as second cr size 6 femur was not available.The procedure was resumed, after a non-significant delay, with a change in surgical technique.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Corrected: d2a, d2b.Additional information: h3, h6: the associated impactor was returned and evaluated.The visual inspection revealed that light wear from use but no damage to the device and no implant stuck in the device.A functional evaluation performed on the device revealed that it is able to actuate as designed in the lab environment.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident for the impactor, insert and femoral component.A review of complaint history based on historical data revealed a similar event for the listed batch of the insert, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history for the part numbers of the insert and femoral component 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 devices.A review of the risk management file revealed this failure modes were previously identified.The anticipated risk level is still adequate.A review concluded that a similar event for the impactor was identified and the following actions were implemented: risk file was revised, impactor knob and impactor ring designs were analyzed, material change was evaluated, functional inspections were evaluated, surgical technique was revised to include precautions for not impacting the rings, design validation and verification were performed for purposed design changes and drawing prints were released.Then, a review of complaints for the journey ii cr locking femoral implant impactor in comparison with the risk management file was performed and concluded that the failure mode was within the anticipated occurrence ranking and overall risk.A historical review concluded that there are no prior actions related to the insert and femoral component and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The impactor is a reusable instrument that can be exposed to numerous surgeries.No evidence on the alleged defects were found on the device, therefore no factors that can contribute to the reported event can be delineated.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 LOCK FEM IMPLANT IMPACTOR
• 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: 22054359
• Report Number: 1020279-2025-00910
• Device Sequence Number: 12113592
• Product Code: JWH
• UDI-Device Identifier: 00885556422892
• UDI-Public: 885556422892
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74011711
• Device Lot Number: 19EBG0287
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female