MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 4 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422354
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an uka surgery had been performed with a journey uni system on an unspecified date, left knee pain worsened for the clinical subject due to progression of osteoarthritis.Clinical subject has not been treated yet, but a conversion to tka is planned.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this clinical study reported on (b)(6) 2015, study id: 17-4049-03; subject id: 15-014, underwent a uka surgery with a journey uni system.Five years later, ae#2; worsening left knee pain was reported.Based on the information provided, the worsening left knee pain was due to the progression of osteoarthritis and not the fault of the manufacturing of the smith and nephew device.The attached crfs supports the complaint, however, no other supporting clinical documentation was provided.According to the complaint, the clinical subject has not been treated, although a conversion to a tka is planned.Since this ae is ongoing, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical documentation be provided this complaint, would be reassessed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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, joint tightness, material in use, patient reaction or patient condition.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: JUNI OX FB FEM SZ 4 RM LL
• 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: 12155210
• Report Number: 1020279-2021-05900
• Device Sequence Number: 4700512
• Product Code: HSX
• UDI-Device Identifier: 03596010627407
• UDI-Public: 03596010627407
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71422354
• Device Catalogue Number: 71422354
• Device Lot Number: UNKNOWN
• 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: 06/30/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71422256/JOURNEY UNI TIBINRT S3-4RM/LL9MM; 71422434/JRNY UNI TIBIAL BASE RM/LL SZ 4; HOSPITAL ADMISSION DATE: 10-MARCH-2015.DATE OF S
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG