MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 4 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421364
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
The associated complaint devices were not returned because they were not revised.A clinical analysis indicated that the crf¿s and the chart sticks were received and reviewed.However, no supporting clinical/medical documents were provided to assist in determining a potential root cause for the patient¿s condition.The action taken by the site was to prescribe the patient a medication therapy and rest.It was reported by the site that the event was assessed as non-serious and the patient was recovering and the condition was resolved.A more thorough investigation cannot be performed with the available documentation.Should additional relevant clinical/medical information become available this complaint will be re-assessed.A review of the manufacturing records for the provided batches did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.There is no evidence that the devices failed to meet specifications.Without the actual product involved or additional clinical/medical documentation our investigation cannot proceed.A relationship between the devices and the event could not be substantiated.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 will be re-opened and reevaluated.

• Brand Name: LGN HK FEM ASSEMBLY SZ 4 RT
• 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: 8334141
• Report Number: 1020279-2019-00551
• Device Sequence Number: 19422615
• Product Code: KRO
• UDI-Device Identifier: 00885556414941
• UDI-Public: 00885556414941
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2019

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: 12/07/2024
• Device Catalogue Number: 71421364
• Device Lot Number: 17LM07751
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019; 01/21/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 06/14/2019; 06/27/2019
• 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