MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POROUS CR FEM SZ 6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	71423256
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Blood or Lymphatic problem (4434); Thrombosis/Thrombus (4440)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a right tka surgery was performed on (b)(6) 2023, the patient experienced deep vein thrombosis of the right lower extremity on (b)(6) 2023.This adverse event was treated with medication, however it remains ongoing.Patient's current health status remains ongoing.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that based on the information provided, the definitive clinical root cause of the reported adverse event cannot be determined.Although we cannot rule the surgical procedure, decreased mobility and the patient 10-year smoking history as the likely contributory factors.Therefore, the causal relationship between the s&n devices and the reported adverse event, cannot be confirmed.Deep vein thrombosis is known to occur prevalently after surgery, particularly orthopedic surgery.According to the report, this adverse event was treated orally with the blood thinner eliquis.Since this adverse event was reported as ongoing, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that thromboembolic diseases including venous thrombosis may occur.This has been identified in adverse events.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should 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.We consider this investigation closed.
Event or Problem Description
It was reported that, after a right tka surgery was performed on (b)(6) 2023, the patient experienced deep vein thrombosis of the right lower extremity on (b)(6) 2023.This adverse event was treated with medication, however it remains ongoing.Currently, the patient is in a state of recovery.
Additional Manufacturer Narrative
Additional information: h6 (health effect - impact code).

• Brand Name: LGN POROUS CR FEM SZ 6R
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17114039
• Report Number: 1020279-2023-01284
• Device Sequence Number: 12424525
• Product Code: MBH
• UDI-Device Identifier: 00885556030394
• UDI-Public: 00885556030394
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K073325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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: 71423256
• Device Catalogue Number: 71423256
• Device Lot Number: 22GTX0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 07/07/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/23/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGN DD XLPE INS W/ JRNY LOCK SZ 5-6 10MM, LOT#:21H.; POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 RT, LOT#:22E.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 105 KG