MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 6 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422356

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a ukr surgery was performed on (b)(6) 2022, the patient returned from an overseas flight and felt presyncopal and with pain in the right calf.The patient was later diagnosed with bilateral pulmonary emboli and extensive right lower leg dvts.The patient is recovering.

Manufacturer Narrative

H3, h6.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided electronic clinical report form documented the serious adverse event as ongoing and moderately severe which led to in-patient/prolonged hospitalization with admit/start date (b)(6) 2023 to discharge on (b)(6) 2023.The adverse event was categorized as an anticipated adverse event which was unrelated to the device, possibly related to the procedure, treated with medication therapies, and currently recovering/resolving.The electronic clinical report form concomitant medication/therapies shows ongoing therapies as of (b)(6) 2023 of enoxaparin (started on (b)(6) 2023) to treat and prevent blood clots as well as rivaroxaban to treat deep vein thrombosis and pulmonary emboli.A prior week of clexane was noted in the electronic clinical report form from 2nd to 9th of feb-2023 for deep vein thrombosis with ongoing ¿blood thinners¿ initiated on 9-feb-2023 that the patient does not remember the (medication) name.The patient is to follow up in clinic in approximately 6 months.Based on the information provided in the electronic clinical report forms, no further clinical factors could be definitively concluded to have contributed to the reported event; however, the ¿immobility from the long flight¿ could not be ruled out.Patient impact beyond the reported bilateral pulmonary emboli and extensive right lower leg deep vein thrombosis and subsequent medication along with hospitalization would not be anticipated as the event was reportedly resolved.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the tibial base and insert 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 complaint history revealed similar events for the fixed bearing femoral over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that thromboembolic diseases, including venous thrombosis, have been identified in the possible adverse effects.Besides, the warnings and precautions section revealed that postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.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 this product and event.At this time, we have no reason to suspect that the product 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 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.We consider this investigation closed.

• Brand Name: JUNI OX FB FEM SZ 6 RM LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16558671
• MDR Text Key: 311473473
• Report Number: 1020279-2023-00566
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627421
• UDI-Public: 03596010627421
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71422356
• Device Catalogue Number: 71422356
• Device Lot Number: 19EM09387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 71422255 / 21KM03032; 71422434 / 21KM09946
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 91 KG