MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM COCR NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021257
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed, the patient presented deep vein thrombosis (dvt) in left leg.This adverse event has been treated with medication is now resolved.No further information is available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the provided crfs have been reviewed.However, based on the information provided, a thorough medical investigation cannot be rendered nor can the root cause of the reported dvt be determined.According to the report, this adverse event has been treated with medication is now resolved.Since no further harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional related clinical information be provided, this complaint will be re-assessed.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, and/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: JRNY II CR FEM COCR NP RT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11885726
• Report Number: 1020279-2021-04671
• Device Sequence Number: 3148743
• Product Code: JWH
• UDI-Device Identifier: 00885556615195
• UDI-Public: 00885556615195
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 74021257
• Device Catalogue Number: 74021257
• Device Lot Number: 1804625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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