MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 RT 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74029236

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that, after a left revision tka had been performed on (b)(6) 2023, while restocking the implants used at the case it was noticed that the replenishment was a jrny ii bcs cnstrd art isrt 3-4 rt 15m.The billing was checked in move medical indicating that a right side poly had been implanted and billed for.The patient was brought back on (b)(6) 2023 and the surgeon did a poly swap to correct side.Patient is doing fine.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H11: corrected data: updated section b3.Report number 1020279-2024-00053 was sent out with incorrect "date received by manufacturer date", correct g4 date should be 28-dec-2023.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, a visual inspection of the image provided revealed that the chart stick specifies that the insert is for the right side.The clinical/medical investigation concluded that based on the limited information provided, human error is the likely contributory factor that led to the implantation right-sided poly in the patient¿s left-knee.Therefore, it could not be concluded that the reported adverse event is related to a mal performance of the implant or implant failure.It is unknown if the instructions for use documents for the knee system was adhered.The impact to the patient beyond the implantation wrong-sided poly, the subsequent revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted 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 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 instructions for use documents for knee systems was performed and revealed in the intraoperative section that the correct selection of the implant is extremely important.According to the label specification, the label should say the device is a right insert.The printed labels were reviewed in the production order and confirmed that the labels stated that this was the an insert for the right knee.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 mix up during set up and/or user error.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: JRNY II BCS CNSTRD ART ISRT 3-4 RT 15M
• 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: 18468067
• MDR Text Key: 332374791
• Report Number: 1020279-2024-00053
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140555
• 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
• Report Date: 02/16/2024

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 Operator: Health Professional
• Device Catalogue Number: 74029236
• Device Lot Number: 20EM00618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female