MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023263
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery performed on an unknown date, the patient experienced a dislocation.This adverse event was solved by a revision surgery on (b)(6) 2025, in which one (1) journ art ins bcs std 5-6 lt11 was removed and a damaged post was observed.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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
H2: additional information ¿d6a¿.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the journey insert significantly worn and discolored.The post is severely degraded.The insertion/extraction slot and lock detail are deformed.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 previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in possible adverse effects that dislocation and subluxation 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.Also, the warnings and precautions section establishes that the implant can become damaged as a result of strenuous activity or trauma.A review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher-than-expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.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 injury, size selected or abnormal loading of limb.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: JOURN ART INS BCS STD 5-6 LT11
• 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: 22353265
• Report Number: 1020279-2025-01132
• Device Sequence Number: 7925276
• Product Code: JWH
• UDI-Device Identifier: 03596010555229
• UDI-Public: 3596010555229
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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: 74023263
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided; 11/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/08/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-2018-26
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male