MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 8 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71425208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2023, patient was diagnosed with deep vein thrombosis of in one of gastrocnemius and popliteal veins.This adverse event was addressed by giving patient medication.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(6).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the devices were not returned.The clinical/medical investigation concluded that, based on the information provided in the electronic case report forms, the definitive clinical root cause of the reported deep vein thrombosis of in one of gastrocnemius and popliteal veins could not be determined.Although we cannot rule the total knee arthroplasty surgical procedure, decreased mobility, weight of 233 pounds as likely contributory factors.Therefore, the causal relationship between the smith & nephew device and the reported deep vein thrombosis, cannot be confirmed.Deep vein thrombosis is known to occur prevalently after surgery, particularly orthopedic surgery.The instructions for use for the porous knee systems does warn, that thromboembolic diseases including venous thrombosis may occur as an adverse event.According to the report, this adverse event was treated with medication.Since this adverse event was reported as recovered/resolved, no further impact to the patient is anticipated.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 device did not reveal similar events for the listed device.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for knee systems revealed that wound hematoma, thromboembolic diseases including venous thrombosis, pulmonary embolus, or myocardial infarction are included in the possible adverse effects section.A historical review concluded that there are no prior actions related to this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.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.

• Brand Name: LGN POR CR HA FEM SZ 8 LT
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23565747
• Report Number: 1020279-2025-01904
• Device Sequence Number: 10205803
• Product Code: MBH
• UDI-Device Identifier: 00885556108543
• UDI-Public: 885556108543
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 05/23/2025
• Device Catalogue Number: 71425208
• Device Lot Number: 10FHA0005A
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 05/26/2015
• 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: 71425327 / LOT NUMBER: 23BM12884.; 71425392 / LOT NUMBER: 22BM11734.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 106 KG