MAUDE Adverse Event Report: VILEX, LLC CHI; CANNULATED MET HEAD IMPLANT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Metal Related Pathology (4530)

Event Date 11/19/2018

Event Type  Injury  

Event Description

Patient was implanted with vilex mpj implants on (b)(6)2018 to address chronic gout.Approximately 6 months post-op, patient begain experiencing pain and periodic swelling at the surgical site.Several years later, patient underwent a revision surgery.During this surgery, dark grey discoloration was present at the mpj joint site.Vilex implants were removed and the joint was fused with a plate.

Manufacturer Narrative

Patient contacted vilex on (b)(6)2023 to address the issues he had after being implanted with chi mpj implants.Patient was initially implanted with vilex mpj implants on (b)(6) 2018 to address chronic gout.Patient began experiencing pain and periodic swelling at the surgical site 6 months post-op and over the next few years.On (b)(6) 2023, patient underwent a revision surgery and dark gray discoloration was present at the mpj joint site.The vilex implants were removed and the joint was fused with a plate.Implants were not returned for evaluation.Patient provided photos of the explanted implants and the surgical site where the discoloration is visible.Based on the photos and procedure report provided by the patient, it was determined that the most likely cause of the dark gray discoloration at the joint site is the presence of titanium particulate resulting from metal-on-metal articulation of two implanted hemi devices.At the first metatarsophalangeal joint, the surgeon resected the surfaces of the proximal phalanx as well as the metatarsal head and implanted both chi and cmhi implants at those locations, respectively, which is not the intended use of the devices.The surgical technique for these devices states 'depending on the condition of the joint, the surgeon has the option to replace eiether the head of the metatarsal or the base of the phalanx, but not both.Under no circumstance should both ends of the joint be replaced.Without any condition or equivocation vilex does not recommend the replacement of both the base of the phalanx and metatarsal head of the same joint.' this is the first occurrence of this type of incident vilex has been made aware of regarding the hemi devices.

• Brand Name: CHI
• Type of Device: CANNULATED MET HEAD IMPLANT
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer (Section G): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: emily womack ; 111 moffitt street; mcminnville, TN 37110 ; 9314747552
• MDR Report Key: 18610998
• MDR Text Key: 334141919
• Report Number: 1051526-2024-00001
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Male