MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Mechanical Problem (1384)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Literature citation: christopher e.Gross, md et al.Surgical treatment of bony and soft-tissue impingement in total ankle arthroplasty.Foot & ankle specialist.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, it was reported by gross et al in "surgical treatment of bony and soft-tissue impingement in total ankle arthroplasty" that in a retrospective study in which several implants from various manufacturers including inbone, it was found that 75 patients (7.5%) required either open (n = 49) or arthroscopic debridement for impingement after tar; 44 patients had >12 months of follow-up, with a follow-up of 26.5 months after their debridement procedure.The mean time to the debridement procedure for all prostheses was 9.3 months, with an average of 21.8 months with inbone.Of the patients with more than 1 year's follow-up from their debridement, 84.1% were asymptomatic; 9 patients (20.4%) had repeat operations after their debridement procedure.Of these, 5 patients required a repeat debridement of their medial or lateral gutters for a failure rate of 11.4%.

• Brand Name: INBONE TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7893599
• MDR Text Key: 120861066
• Report Number: 1043534-2018-00137
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2018

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
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• 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