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 Problems Loss of Range of Motion (2032); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Literature citation: thomas s.Roukis.Management of massive hindfoot osteolysis secondary to failed inbone i total ankle replacement.Clin podiatr med surg.2015.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 roukis in "management of massive hindfoot osteolysis secondary to failed inbone i total ankle replacement" that the patient was involved in a motorcycle accident in 1991 and had several surgeries.In (b)(6) 2009 the patient underwent a tar with inbone and internal fixation removal from the foot; and open posterior-central strayer type gastrocnemius recession of the left lower leg.At the time of referral to the author, she was experiencing pain with activities globally about the anterior aspect of the ankle, medial gutter, and dorsal midfoot.She had noticed the ankle having less motion over time and also that she developed worsening toe-walking with external rotation of her foot.It was found on films that the saddle talar component and poly insert failed and were associated with massive cystic changes within the talus and calcaneus secondary to aseptic osteolysis.The patient underwent a revision surgery with a conversion to inbone ii as well as impaction cancellous allograft bone graft impregnated with autogenous proximal tibia bone marrow aspirate.A percutaneous tendo-achilles lengthening and posterior capsule release was performed to enhance ankle dorsiflexion.

• 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: 7893932
• MDR Text Key: 120866130
• Report Number: 1043534-2018-00139
• 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?: Yes
• 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
• Patient Age: 61 YR