MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had patient had a journey uni implanted (b)(6) 2019.The patient recently walking in bush, stumbled and knee felt different.Patient had loosening of tibial component.After removal of component, surgeon felt there was a healed fracture around the medial cortex of tibia.Removed tibial component, and cemented new component in.Revision surgery was performed on (b)(6) 2020.
Additional Manufacturer Narrative
It was reported that a patient had a revision surgery performed due to loosening of tibial component after a stumble.After removal of component, surgeon felt there was a healed fracture around the medial cortex of tibia.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed at this time.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.After the stumble, the patient stated the knee felt different.This event might be a contributing factor of the device loosening.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10356985
• Report Number: 1020279-2020-03648
• Device Sequence Number: 2399281
• Product Code: HSX
• UDI-Device Identifier: 00885556088043
• UDI-Public: 00885556088043
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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 Model Number: 71422425
• Device Catalogue Number: 71422262
• Device Lot Number: 17AM20691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JRNY UNI TIBINRT S5-6LM/RL9MM 71422262/16CM10896; JUNI OX FB FEM SZ 6 LM RL 71422346/15FM15230; JRNY UNI TIBINRT S5-6LM/RL9MM 71422262/16CM10896; JUNI OX FB FEM SZ 6 LM RL 71422346/15FM15230
• Outcome Attributed to Adverse Event: Required Intervention