MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 4 RT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71423234

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

Patient Problems Purulent Discharge (1812); Inflammation (1932); Impaired Healing (2378)

Event Date 08/27/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, after a right total knee arthroplasty performance on (b)(6) 2022 due to stage iv osteoarthritis of the right knee, on the 10th day after the operation (b)(6),the patient had red, swollen, hot and exudative wounds.The dressing was changed, but the wound healed poorly.In order to treat this, the patient underwent debridement in the hospital.The patient health status is unknown.

Manufacturer Narrative

H3,h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, based on the documentation provided, the post-operative wound infection within 30 days of the right total knee arthroplasty was a contributing factor to the reported wound dehiscence and led to additional medical and surgical interventions; however, the origin of the reported infection could not be concluded.It was communicated that the device was not explanted and no revision surgery was required.The patient¿s current health status is unknown.The patient impact included the inflammatory wound changes, infection, dehiscence, hospital admission and radical debridement with post-surgical therapies.This does not confirm a malperformance of the implanted device.Further patient impact could not be determined, although a transient post-op rehabilitation phase would be anticipated.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 part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in warnings and precautions, postoperative section that use extreme care in patient handling is needed and postoperative patient care and directions and warnings to patients by physicians are extremely important.Also post-surgical wound infection and delayed wound healing have been identified as possible adverse effects.A review of the risk management file 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.A review of the sterilization records revealed the batch was sterilized within normal parameters.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 include loss of sterility during procedure, post-operative healing issue, 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: LEGION PS NP FEM SZ 4 RT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 16649699
• MDR Text Key: 312400531
• Report Number: 1020279-2023-00734
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556031049
• UDI-Public: 00885556031049
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71423234
• Device Catalogue Number: 71423234
• Device Lot Number: 21MM05062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention