MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022213
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374); Swelling/ Edema (4577)
Date of Event	04/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2023, on (b)(6) 2023 the patient experienced prosthetic failure when the base plate fractured as she was getting out of the car.A revision surgery was performed on (b)(6) 2023 to address this adverse event.Current health status of patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per the complaint details, the patient required revision approximately 3.5 months post implantation due to a fractured baseplate after an adverse event when ¿simply standing and getting out of a car¿.The patient reported a history of stiffness/tightness in the knee joint, post-surgery with immediate swelling and discomfort following the adverse event.Reportedly, an x-ray was performed the following day and patient was scheduled for revision.Other than an invoice on (b)(6) 2023, as of the date of this medical investigation, clinical documentation has not been received; therefore, it is unknown if the fracture could have resulted from mechanical issues, traumatic injury, and/or other factor(s) and definitive contributing clinical factors could not be concluded.No supporting evidence has been provided that would indicate that the event is related to a mal performance of the component(s).Reportedly, the patient impact related to the broken baseplate was swelling, discomfort, diagnostic imaging and and need for additional surgical intervention/revision with unknown components.The patient did report post-surgical complications that were ¿caused by either a reaction to stress or bad reaction to general anesthesia¿.No further medical assessment can be rendered at this time.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 devices.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.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.For the journey tibia base, according with the inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic 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.
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2023, the patient experienced a prosthetic failure when she was getting out of the car on (b)(6) 2023.The patient described it as a base plate fracture, accompanied with immediate swelling and discomfort.X-rays were taken the following day, on (b)(6) 2023, and the patient was scheduled for revision surgery that was performed on (b)(6) 2023.The patient reported a complicate recovery after the revision surgery, which resulted in two (2) days of hospitalization, due to nausea, vomiting and low blood pressure.Patient's current health status is healthy, with no chronic issues other than continued stiffness/tightness in the knee joint, post-surgery.
Additional Manufacturer Narrative
Section h3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the tibial baseplate and insert.These devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided imaging does not appear to show a fractured tibial baseplate; however, there does appear to be a shadow anterior of the knee joint space, which likely represents an anteriorly displaced articulating insert.The operative report confirms the suspected anteriorly displaced/dislocated articulating insert noted on the provided radiological imaging as it was "immediately noted to be unlocked".The unlocked/undamaged insert led to the insert dislocation and strongly suggests that the primary insert had not fully locked into the tibial baseplate, as no damage or material was reportedly seen upon surgeon inspection; therefore, a user technique/procedural variance cannot be ruled out as a contributing factor.Of note, the primary 9mm medial dished insert was revised to an upsized thickness (10mm) cr insert.The patient¿s acute symptoms of ¿immediate swelling and discomfort¿ while getting out of the vehicle were most likely a direct result of the insert disassociation.The patient impact included the reported post-operative stiffness/tightness (anticipated) with an unanticipated acute onset of swelling and discomfort after exiting a vehicle, diagnostic imaging, aspiration, and subsequent revision along with a reported 2-night hospitalization which may have been due to procedure-related complications/¿caused by either a reaction to stress¿or bad reaction to general anesthesia¿.An august 2023 office note indicated patient was ¿doing well 4 months out from revision¿ with ¿no pain¿ and ¿full range of motion¿.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 devices.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.Also, the possible adverse effects section revealed 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.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 this products and event.According with the inspection procedure for the tibial baseplate, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade the titanium alloy shall be controlled.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 user technique/procedural variance, traumatic injury, patient condition and/or anatomy, postoperative care, size selected or abnormal loading of limb.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 TIBIA BASE NP RT SZ 3
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18078960
• Report Number: 1020279-2023-02159
• Device Sequence Number: 20765767
• Product Code: JWH
• UDI-Device Identifier: 03596010554277
• UDI-Public: 03596010554277
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/09/2024

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: Lay User/Patient
• Device Catalogue Number: 74022213
• Device Lot Number: 22KM06984
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/20/2023; 05/08/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/21/2023; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421029/LOT# 22EM03486; 74021156/LOT# 20FM11495; 74021441/LOT# 22HM14394
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 66 KG