MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 5-6 10MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74025652
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
[ study: journey ii cr retro; subject id: nyu-0142 (198320142); ae#: 2 ].It was reported that, after a journey ii cr system had been implanted, the clinical subject experienced dvt in left leg.This adverse events was resolved with medications.
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, per complaint details, the clinical subject experienced a left leg dvt (ae#2) which resolved with medication.The requested clinical documentation had not been provided as of the date of this medical investigation; therefore, the reported dvt (ae#2) could not be further assessed.Although dvts are a known post-surgical potential risk/complication, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported event and medication therapy could not be determined, although the (ae#2) had a resolved outcome.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available the medical investigation task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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, injury, infection 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 ISRT XLPE RT SZ 5-6 10MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11580451
• Report Number: 1020279-2021-02439
• Device Sequence Number: 14672917
• Product Code: JWH
• UDI-Device Identifier: 00885556422458
• UDI-Public: 00885556422458
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74025652
• Device Catalogue Number: 74025652
• Device Lot Number: B1804625
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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; Other; Required Intervention