MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED

Model Number	71421377
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a legion implant on the left side on (b)(6) 2019, the patient the patient started experiencing a haemarthrosis of the knee on (b)(6) 2019; rivaroxaban restarted when swelling started.Clexane was given, and antibiotics /apixaban withheld.This adverse event has not been treated and is, therefore, ongoing.
Additional Manufacturer Narrative
D4: lot number and expiration date added.H4: manufacture date added.(b)(4).
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the provided crfs indicate that the reported mild hemarthrosis of the knee was an anticipated, serious adverse event, definitely related to the study procedure, but not the study device.The event was documented as resolved after hospitalization from (b)(6) 2021 to (b)(6) 2021 which included withholding the rivaroxaban/antibiotics/apixaban, covering with clexane and gradually restarting/increasing the apixaban on (b)(6) 2021.The patient withdrew from the study due to ill health per crf so the current patient status is unknown.The clinical root cause of the reported event could not be definitively concluded; however, joint hemarthrosis is a known potential post-operative complication following tka and tha procedures.The patient impact beyond the reported hemarthrosis, medication changes and prolonged hospitalization could not be determined as the event resolved per the crf.No further medical assessment could be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication, traumatic injury, patient medical history or condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported mild hemarthrosis of the knee (ae#1) was an anticipated, serious adverse event, definitely related to the study procedure, but not the study device.The event was documented as resolved after hospitalization from (b)(6) 2021 which included withholding the rivaroxaban/antibiotics/apixaban, covering with clexane and gradually restarting/increasing the apixaban on (b)(6) 2021.The patient withdrew from the study due to ill health per crf so the current patient status is unknown.The clinical root cause of the reported event could not be definitively concluded; however, joint hemarthrosis is a known potential post-operative complication following tka and tha procedures.The patient impact beyond the reported hemarthrosis, medication changes and prolonged hospitalization could not be determined as the event resolved per the crf.No further medical assessment could be rendered at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication, traumatic injury, patient medical history or condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN HK FEM ASSEMBLY SZ 7 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11773604
• Report Number: 1020279-2021-03733
• Device Sequence Number: 17088447
• Product Code: KRO
• UDI-Device Identifier: 00885556414880
• UDI-Public: 00885556414880
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: 71421377
• Device Catalogue Number: 71421377
• Device Lot Number: 16MM04283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 08/06/2021; 09/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/09/2021; 09/01/2021; 09/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 101