MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74027231

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, a left sided journey bcs tka had been performed on (b)(6) 2023, in which one (1) jrny ii bcs xlpe art isrt sz 3-4-rt 9mm was used.The operation went well and the patient was discharged.During a follow-up it was noticed that the label for the insert used was for a right sided insert.Based on an investigation, it does appear that a right bcs insert was implanted into a left knee.Patient outcome is unknown.

Manufacturer Narrative

Section h6 was updated.Section h10: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, human error contributed to the inadvertent implantation of right-sided articulating insert into the left knee.The outer box was reportedly not available, and the event was not noted until ¿came to light after six weeks of procedure¿ that the label for the insert used was for a right sided insert.However, the chartstiks (allegedly labeled as a right-sided articulating insert for which the complaint is based) would have been the same chartstiks in the operating theatre to be reviewed/compared to the outer box prior to use.The patient impact includes the inadvertent implantation of the contralateral (right-sided insert) component into the left knee.Although no patient complaints of signs/symptoms of a mechanical nature have been reported as of the date of this medical investigation, the construct may increase risks of poor kinematics, pain, tightness, patellar/femoral maltracking and/or instability, and increased wear, possible osteolysis; therefore, additional interventions and/or early revision cannot be ruled out.Further patient impact could not be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that according to the device history record, this was labeled properly as a right handed insert and just possibly used accidentally.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 that the surgeon should be familiar with the technique and an adequate inventory of implant sizes should be available at the time of surgery.Additionally, revealed 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.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.Based on the information provided, the unsatisfactory experience could be confirmed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include user error.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.Internal complaint reference number: (b)(4).

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the operation went well and the patient was discharged.Moreover, after the investigation was performed it was determined that the issue does not meet the criteria to be reportable, since a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that according to the device history record, this was labeled properly as a right handed insert and just possibly used accidentally.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.Therefore, based on the information provided, human error contributed to the inadvertent implantation of right-sided articulating insert into the left knee.Use error did not lead to a device-related death or serious injury.This event is not reportable pursuant to applicable regulations.Internal complaint reference number: case (b)(4).

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM
• Type of Device: 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: 18843164
• MDR Text Key: 336959521
• Report Number: 1020279-2024-00499
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 00885556179017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

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
• Device Catalogue Number: 74027231
• Device Lot Number: 23JM11517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 04/24/2024
• Supplement Dates FDA Received: 04/18/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention