MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL CR COCR SZ 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71422935
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Event or Problem Description
It was reported that after a tka performed on (b)(6)2019, the patient experienced a pulmonary thromboembolism on (b)(6)2019.The patient required medication therapy and is now recovered.
Additional Manufacturer Narrative
H3, h6.Given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the bilateral anthem cruciate retaining study patient experienced a pulmonary thromboembolism 5 days post total knee arthroplasty and required medication therapy.Reportedly the patient is now recovered.The provided electronic clinical report forms documented the adverse event as an anticipated, mild, and non-serious adverse event and was unrelated to the study device but possibly related to the bilateral study procedure and required medication therapy with start date as (b)(6) 2019 with patient outcome documented as recovered/resolved with an end date of (b)(6) 2020.Post-operative thrombus/pulmonary thromboembolism is a known possible risk with any surgical procedure and is not indicative of a malperformance of the component(s).The patient impact beyond the reported thromboembolism with subsequent medication therapy cannot be determined.No further medical assessment is warranted at this time.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 devices.A review of the instructions for use documents for total knee system revealed that wound hematoma, thromboembolic diseases including venous thrombosis, pulmonary embolus, or myocardial infarction may occur as an adverse effect.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 patient condition and/or medical history.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: ANTHEM FEMORAL CR COCR SZ 5 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 16632662
• Report Number: 1020279-2023-00681
• Device Sequence Number: 7150061
• Product Code: JWH
• UDI-Device Identifier: 00885556655801
• UDI-Public: 00885556655801
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 71422935
• Device Catalogue Number: 71422935
• Device Lot Number: 17KM02474
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/21/2023
• Date Device Manufactured: 10/03/2017
• 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: ANTHEM CR HF INSERT SZ 3-4 9MM, LOT#:18DM21108.; ANTHEM TIBIAL BASE PLATE SZ 3 LT, LOT#:19FM22731.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 65 KG