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

Model Number	74022213
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia was performed due to stiffening.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms ¿stiffening¿ is a well-known post-operative complication (most likely due to arthrofibrosis) for which an mua is commonly performed and does not indicate a mal-performance of the components (b)(4).Based on the patient¿s symptoms, possible lateral tracking and atypical intraoperative findings of the native patella, an undiagnosed early ligamentous instability, non-resurfacing during the primary tka, and the suspected ¿abnormal bone metabolism¿ could not be ruled out as possible contributing factors to the symptoms/subsequent revision and does not support a mal-performance of the components (b)(4).The patient impact beyond the reported symptoms, possible increased radiological exposure, subsequent mua, conservative measures over the course of the implant and resurfacing revision with insert upsizing could not be determined.No further medical assessment can be rendered at this time.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to procedural/ user error and surgical complication.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 3
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9235256
• Report Number: 1020279-2019-03731
• Device Sequence Number: 16791304
• Product Code: JWH
• UDI-Device Identifier: 03596010554277
• UDI-Public: 03596010554277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 74022213
• Device Catalogue Number: 74022213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention