MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 6; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74021156
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Injury (2348)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right knee stiffness was resolved with manipulation under anesthesia.
Additional Manufacturer Narrative
Correction on patient and device codes.
Additional Manufacturer Narrative
He associated complaint devices were not returned.A clinical evaluation was conducted and from a jny retro study three events were reported it was reported that right knee stiffness was resolved with manipulation under anesthesia.¿ ¿it was reported that patient had left lower leg deep vein thrombosis after right knee replacement.Event was treated with rivaroxaban and was resolved¿ ¿it was reported that patient had illiotibial band syndrome and it was resolved with a steroid injection.¿ details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided the root cause of the reported stiffness cannot be determined.Root cause of the arthrofibrosis could be contributed to concomitant medical problems and history, dvt, medical investigation report.This document contains information confidential and proprietary to smith and nephew.Released iliotibial band syndrome.1 arthrofibrosis and mua 2 dvt treated with medication, 3) iliotibial band syndrome with steroid injection all incidents are listed as having been resolved.No further medical assessment is warranted based on the information provided.Ankylosis (arthrofibrosis complaint) immobility of the joint due to the formation of bone, cartilaginous or fibrous tissues around the joints.Fibrosis (arthrofibrosis complaint) the formation of fibrous tissue.Thrombosis/thrombus (dvt complaint) the formation of a blood clot in the lumen of a vessel or heart chamber.Additional surgery (arthrofibrosis complaint) surgical intervention that was not planned and needed to be performed in addition to other interventions including surgical ones.Medication required (dvt treatment) patient required additional medication or additional dose of existing medication.Without the actual product involved and/or device information, our investigation cannot proceed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 6
• 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: 8746770
• Report Number: 1020279-2019-02512
• Device Sequence Number: 1330136
• Product Code: JWH
• UDI-Device Identifier: 00885556422830
• UDI-Public: 00885556422830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2019

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 Expiration Date: 08/01/2026
• Device Catalogue Number: 74021156
• Device Lot Number: 16HM02766
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 06/11/2019
• Initial Report FDA Received Date: 06/29/2019
• Supplement Report FDA Received Date: 06/29/2019; 10/29/2019
• 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