MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74027234
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to recurrent effusions and knee instability.The insert was exchanged.The patient presented at 1 year postoperative with recurrent painful knee effusions.He has had multiple knee aspirations.He has been to treat his effusions without success.He has been ruled out for periprosthetic joint infection.He has signs of knee instability on exam.His patella was not resurfaced at the original procedure.Given his ongoing pain and recurrent swelling, a revision surgical treatment was recommended.
Additional Manufacturer Narrative
The device, used in treatment was 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 a manipulation under anesthesia is commonly performed and does not indicate a mal-performance of the components.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 total knee arthroplasty, 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.The patient impact beyond the reported symptoms, possible increased radiological exposure, subsequent manipulation under anesthesia, 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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but are not limited to articular surface geometry.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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM
• 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: 9247969
• Report Number: 1020279-2019-03750
• Device Sequence Number: 3934642
• Product Code: JWH
• UDI-Device Identifier: 00885556179161
• UDI-Public: 00885556179161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 74027234
• Device Catalogue Number: 74027234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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