MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference case (b)(4).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.
Event or Problem Description
It was reported that after a tka surgery performed in (b)(6) 2021, in which a journey ii bcs femur size 5, a journey tibia size 5, and a patella 32 x 7.5 polyethylene 9mm bcs were implanted, the patient experienced inflammation caused by a suspected allergic reaction.It is currently unknown if the patient is allergic to any of the implant materials.All orthopedic surgeons have declined to attempt surgical revision until confirmation of the patient¿s potential allergy to the current implants is obtained.
Additional Manufacturer Narrative
Given the nature of the reported incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the patient reported undergoing multiple diagnostic tests; however, clinical or medical documentation has not been provided as of this investigation.The instructions for use related to knee systems lists metal sensitivity or allergic reactions as possible adverse effects.Given the limited information available, a definitive clinical root cause cannot be determined, and sensitivity or allergy to implant materials cannot be confirmed.There is no evidence to suggest component malfunction.The patient impact, beyond knee effusion fluid accumulation and inflammation, cannot be assessed.The materials of the implants were revised and the composition is the following: for the journey ii bcs femoral oxinium right size 5 the main component is niobium alloy, following by niobium (nb), oxygen (o), aluminum (al), boron (b), cadmium (cd), carbon (c), chlorine (cl), chromium (cr), cobalt (co), copper (cu), hafnium (hf), hydrogen (h), iron (fe), lead (pb), magnesium (mg), manganese (mn), molybdenum (mo), nickel (ni), nitrogen (n), phosphorus (p), silicon (si), tantalum (ta), thorium (th), tin (sn), titanium (ti), tungsten (w), uranium (u) vanadium (v) and zirconium (zr).Regarding the journey tibial baseplate nonporous right size 5 the main components: titanium ¿ aluminum ¿ vanadium alloy forgings and the complete list is nitrogen (n), carbon (c), hydrogen (h), iron (fe), oxygen (o), aluminum (al), vanadium (v), yttrium (y), titanium (ti).For the journey ii bcs xlpe articular insert size 5-6 right 9mm the material is manufactured from highly crossed linked polyethylene (xlpe).Use of this implant will expose patients to polyethylene, titanium (ti) and aluminum (al) at lower levels.In reference to the gen ii 7.5mm resur pat 32mm the material is manufactured from ultra-high molecular weight polyethylene (uhmwpe) or cross-linked polyethylene (xlpe).The component material for implantable devices is provided on the outside carton label.And with respect to the rally mv ab bone cement 40 grams the liquid components are methyl methacrylate; n,n-dimethyl-p-toluidine; hydroquinone.And the powder components: poly-metil-methacrylate; barium sulfate; gentamicin sulphate; benzoyl peroxide.Reviews of the production orders did not reveal manufacturing abnormalities that could have caused or contributed to the reported incidents.Reviews of complaint histories for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.For the journey tibia base np rt sz 5, a review of complaint history revealed similar events for the listed part number over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.Reviews of the risk management files revealed these failure modes were previously identified.The anticipated risk levels are still adequate.Historical reviews concluded that there are no prior actions related to these products and events.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 events include irregular implant interactions, abnormal motion over time, or patient conditions.Based on these investigations, the need for corrective actions is not indicated.Should additional information be received, the complaints will be reopened.No further investigations are warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider these investigations closed.

• Brand Name: JRNY II BCS FEMORAL OXIN RT SZ 5
• 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: 23006129
• Report Number: 1020279-2025-01523
• Device Sequence Number: 16073406
• Product Code: JWH
• UDI-Device Identifier: 00885556169919
• UDI-Public: 885556169919
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74022115
• Device Lot Number: 21FM24957
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 06/30/2021
• 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: (B)(6).; (B)(6).; (B)(6).; (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male