MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER

Model Number 74012414

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Failure to Align (2522)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  malfunction  

Event Description

It was reported that during tka procedure the locking screw of the journey dcf ap fem cut blk 4 came loose and the block fell apart.The procedure was finished using the same device.It is unknown when this occurred.No delay or harm to the patient reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection could not confirm the stated failure.The device was manufactured in 2014.This instrument exhibit signs of significant use and wear.A functional evaluation confirms the cutting block knob is seized in place.The knob is unable to lock and unlock as intended.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; 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 4
• 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: 10469855
• MDR Text Key: 204855727
• Report Number: 1020279-2020-04292
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556660
• UDI-Public: 03596010556660
• 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
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012414
• Device Catalogue Number: 74012414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1