MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK TIBIAL BASE SZ 2 RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421902
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented swelling and redness in the right knee.The cause of the swelling and redness is unknown.The patient was prescribed to take rest and medication therapy.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that the crf¿s and the chart sticks were received and reviewed.However, without supporting clinical/medical documents a thorough investigation cannot be performed.Should additional relevant clinical information become available this complaint can be re-assessed.A review of the manufacturing records for the provided batches did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.
Additional Manufacturer Narrative
Corrected information of initial report.

• Brand Name: LEGION HK TIBIAL BASE SZ 2 RIGHT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8352820
• Report Number: 1020279-2019-00708
• Device Sequence Number: 16693934
• Product Code: KRO
• UDI-Device Identifier: 00885556108918
• UDI-Public: 00885556108918
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2019

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 Catalogue Number: 71421902
• Device Lot Number: 17KBP0050A
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019; 01/21/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 02/20/2019; 06/14/2019
• 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