MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012413

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/30/2020

Event Type  Injury  

Event Description

It was reported that, during a tka procedure, the journey dcf ap femoral cutting block sz 3 presented contamination of inside part of block- chemicals remaining around middle part of block.Multiple methods of sterilization were trialed.The procedure was cancelled.

Manufacturer Narrative

The device, used in treatment, was not received for evaluation and the reported event could not be confirmed.The shipping information was provided, and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.If the device is received in the future, the complaint will be reopened to evaluate.The clinical/medical evaluation concluded that based on the documentation provided, the root cause of the reported event could not be definitively concluded; however, the use of automatic pre-wash cycle and final rinsing without deionized water, the auto-wash loading technique, or verifying cleaning technique could not be ruled out as potential contributing factors to the reported events.See ¿s&n ortho devices 01004 v2 01/2015: devices with challenging design features¿.The event was not a failure of the device design or cleaning protocols but likely technique within the hospital.Patient impact beyond the reported approximate 30-minute surgical delay while anesthetized and procedure cancellation would not be anticipated as there was no patient injury reported and the devices were outside of the patient.No further medical assessment can be rendered at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.A potential probable cause could be but is not limited to contamination, or difficulty cleaning.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: JOURNEY DCF AP FEM CUT BLK 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11057640
• MDR Text Key: 223200748
• Report Number: 1020279-2020-07708
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556653
• UDI-Public: 03596010556653
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012413
• Device Catalogue Number: 74012413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other