MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71423358

Device Problems Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that after a right tka surgery performed on (b)(6) 2022 it was noticed that the wrong sided insert had been implanted in to the patient (legion hk gd motion isrt 18mm sz 4-5 lt).The surgeon was informed immediately.A revision surgery was made on (b)(6) to correct this issue.During the initial surgery all implants were presented to the surgeon and the scrub nurse for approval.The patient current health status is unknown.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Section d4, h4 and h6 were updated.Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.This was a hospital/human error not a malperformance of the product or labeling.The patient's current condition is unknown.The patient impact beyond the reported events and the extra surgery, could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.A review of the manufacturing records 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 section that the correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc.Generally, the largest cross-section component which will allow adequate bone support to be maintained is preferred.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to human error/user variance.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).

Event Description

It was reported that a 'never event' occurred as follows: a right total knee revision surgery was scheduled for (b)(6) 2022.As per surgeon¿s usual practice, the theatre team had arranged to have the s+n standard legion kit, with the hinged knee (hk) option available.Prior to the case starting, the surgeon notified the team that he would need to perform a legion hk procedure.This procedure was relatively uncommon and the staff highlighted that they would need support throughout the case.The s+n representative supported the case and contacted more experienced colleagues when she did not know the answers to the surgeon¿s questions.As per standard practice, the rep obtained the implants from a loan supply and brought them into the theatre to check with the operating team.The descriptions, sizes and dates of the implants were all checked and confirmed by the scrub nurse and the surgeon.Implantation of the legion hinged knee (hk) system was uneventful and the surgeon was satisfied with the balance and movement of the joint prior to closing the wound.Later that day, while checking the information about the implants used, s+n staff realized that the incorrect 18mm sz 4-5 legion hk gd motion insert had been placed: left instead of right.The theatre team and the surgeon were immediately informed.The patient had returned to the ward and had already eaten so was not able to return to the theatre that day.The patient was brought back on (b)(6) 2022 so the mistake could be rectified.The patient is fit and well, as per most recent clinic letter.For s+n primary and standard revision knee implants, the articular insert is not sided.The surgeon and scrub nurse were unaware the hinged insert was sided and did not note the side when checking this component.The hospital healthcare providers indicate that the labeling could be improved on sided products as it is usual that the team does not know what approach will be used until the patient is assessed in theatre.

Manufacturer Narrative

Additional information: h8.Corrected data: b5, d8 (device is not available for evaluation), h6(health effect - impact code, medical device problem code).

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.This was a hospital/human error not a malperformance of the product or labeling.The patient's current condition is unknown.The patient impact beyond the reported events and the extra surgery, could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.A review of the manufacturing records 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 that the correct selection of the implant has been identified in warnings and precautions.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to intraoperative error.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).

• Brand Name: LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, 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 ; 5123913905
• MDR Report Key: 15274584
• MDR Text Key: 298385183
• Report Number: 1020279-2022-03793
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556030813
• UDI-Public: 00885556030813
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71423358
• Device Catalogue Number: 71423358
• Device Lot Number: 18JM07428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2018
• 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): Hospitalization; Required Intervention