MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE ® I; SMALL JOINT COMPONENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Arthritis (1723); Bacterial Infection (1735); Failure of Implant (1924); Pain (1994); Staphylococcus Aureus (2058); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Allegedly, per mulhern et al, salvage of failed total ankle replacement using a custom titanium truss: case study: patient presented with a chief complaint of left ankle pain.On physical examination, the ankle demonstrated a limited range of motion with crepitus, and advanced imaging demonstrated degenerative arthritis of the ankle joint.After extensive discussion of the conservative and surgical treatment options, the patient elected to undergo tar.In (b)(6) 2013, approximately 2 years after the index procedure, the patient underwent subtalar joint arthrodesis and tar revision.The polyethylene and talar components were replaced with bone cement owing to progressive subtalar osteoarthritis and talar subsidence.Removal of the subtalar joint screw was performed in (b)(6) 2013.The patient subsequently developed a deep complex abscess of the left foot, necessitating an incision and drainage procedure in (b)(6) 2013.Cultures from the abscess revealed staphylococcus aureus as the infective agent; bone cultures were not taken at that time.Nuclear medicine imaging after the incision and drainage confirmed infection of the prosthesis.In (b)(6) 2014, approximately 3 years after the initial tar, the implant was explanted, and an antibiotic cement spacer was placed into the bony void.Cultures take at explantation revealed the same infective agent as in the abscess evacuated 4 months earlier.In (b)(6) 2014, once the infection had resolved, the spacer was removed, and new ankle prosthesis was implanted.After this most recent revision, the patient continued to have pain and demonstrated continued talar subsidence on serial radiographs.Tibiotalocalcaneal arthrodesis was discussed as a salvage option for the patient.Fully informed, the patient elected to proceed.In (b)(6) 2015, approximately 4 years after the index tar, the patient underwent explantation of the tar and tibiotalocalcaneal arthrodesis with custom titanium truss and retrograde hind foot im nailing.

• Brand Name: INBONE ® I
• Type of Device: SMALL JOINT COMPONENT
• 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 ; 901290-566
• MDR Report Key: 5458321
• MDR Text Key: 38977084
• Report Number: 1043534-2016-00017
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1