MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a legion hk system had been implanted on the left side of a patient, on (b)(6) 2018, the patient started experiencing a lateral patellofemoral crepitus on (b)(6) 2020.This adverse event has not been treated and is, therefore, ongoing.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-valid event.There is no information that confirms that the lateral patellofemoral crepitus was caused by the device.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LGN HK FEM ASSEMBLY SZ 5 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781912
• Report Number: 1020279-2021-03809
• Device Sequence Number: 19628048
• Product Code: KRO
• UDI-Device Identifier: 00885556414897
• UDI-Public: 00885556414897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 71421375
• Device Catalogue Number: 71421375
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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