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

Device Problems Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthritis (1723); Bone Fracture(s) (1870)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Literature citation: markus preis et al.Conversion of painful tibiotalocalcaneal arthrodesis to total ankle replacement using a 3-component mobile bearing prosthesis.Foot and ankle surgery.2017; vol 0.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, in an article written by pries et al titled "conversion of painful tibiotalocalcaneal arthrodesis to total ankle replacement using a 3-component mobile bearing prosthesis" another article by pellegrini et al titled "conversion of tibiotalar arthrodesis to total ankle arthroplasty" it was reported that 14 patients underwent inbone total ankle replacements along with various other manufactures devices that were implanted.Patient complications were reported as malleolar fracture intraoperatively, post-op component loosening, subtalar osteoarthritis, varus hindfoot deformity requiring calcaneal osteotomy, ankle impingement requiring open debridement, and posterior ankle impingement requiring arthroscopic debridement.It is not know if these complications were related to the patients with inbone tars as products from multiple manufacturers were implanted during the procedures.

• Brand Name: INBONE(R) 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: 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7890638
• MDR Text Key: 120767848
• Report Number: 1043534-2018-00121
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/24/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention