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

Model Number	74021166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented left knee patellar impingement and crepitus.Event was treated with irrigation and debridement.
Additional Manufacturer Narrative
It was reported that the patient presented left knee patellar impingement and crepitus.The event was treated with irrigation and debridement.The affected compliant devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential causes of the reported event could include but not limited to fit/sizing, wear or alignment of device.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP LT SZ 6
• Common Device Name: PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10014636
• Report Number: 1020279-2020-01416
• Device Sequence Number: 2952915
• Product Code: JWH
• UDI-Device Identifier: 00885556422779
• UDI-Public: 00885556422779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 74021166
• Device Catalogue Number: 74021166
• Device Lot Number: 18AM22043
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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