MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421367
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was treated for pain and inflammation.It was discovered that the patient had an infection.All components were revised except for the patella.The patient had undergone a washout a year prior to this revision.
Additional Manufacturer Narrative
It was reported that the patient was treated for pain and inflammation.It was discovered that the patient had an infection.All components were revised except for the patella.The associated legion hinge knee baseplate, femoral wedge, pressfit stems, offset coupler, tibial wedge and tibial cone, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.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 devices 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.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.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 the device or additional information be received, the complaint will be reopened.

• Brand Name: LGN HK FEM ASSEMBLY SZ 7 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: 9247974
• Report Number: 1020279-2019-03756
• Device Sequence Number: 16657642
• Product Code: KRO
• UDI-Device Identifier: 00885556414927
• UDI-Public: 00885556414927
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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 Expiration Date: 01/04/2023
• Device Model Number: 71421367
• Device Catalogue Number: 71421367
• Device Lot Number: 16CM12295
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 03/13/2020
• 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