MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422261
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Implant Pain (4561)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2021, with a uni journey system, the patient experienced pain.X-rays indicated that the journey uni tibinrt s5-6lm/rl8mm was not in its position.This adverse event was solved by a revision surgery on (b)(6) 2022, in which the journey uni tibinrt s5-6lm/rl8mm was removed.The patient's health status is stable.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the clinical/medical investigation confirmed the failure mode through the x-ray analysis.It was concluded that based on the documentation provided, the root cause of the reported revision due to ¿damage¿ and pain was most likely the uni-knee insert dislocation allowing contact between the femoral condyle and the tibial baseplate; however, the root cause of the insert dislocation could not be definitively concluded.The amount of periprosthetic tissue debris during the approximate 4 months in-vivo raises suspicion of possible post-operative trauma or incomplete seating/locking of the tibial insert into the tibial baseplate during the initial uni-knee procedure.The assessed patient impact is the reported pain, insert dislocation, revision/conversion to tka and findings indicative of metallic tissue debris.Further patient impact could not be determined; however, it was reported that the patient health condition is stable.No further medical assessment can be rendered at this time.A review of the manufacturing records 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 revealed that improper fixation, and/or migration of the components could cause possible adverse effects.Also, the warnings and precautions section establish that the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of possible adverse effects.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.The contribution of the device to the reported event could be corroborated as the device migration led to a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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 UNI TIBINRT S5-6LM/RL8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 13996109
• Report Number: 1020279-2022-01484
• Device Sequence Number: 14538050
• Product Code: HSX
• UDI-Device Identifier: 03596010582201
• UDI-Public: 03596010582201
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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 Model Number: 71422261
• Device Catalogue Number: 71422261
• Device Lot Number: 21GM05052
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown