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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. INBONE ® II SMALL JOINT COMPONENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Arthritis (1723); Unspecified Infection (1930); Staphylococcus Aureus (2058)
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.
 
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Brand NameINBONE ® II
Type of DeviceSMALL 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 Key5458324
MDR Text Key38979893
Report Number1043534-2016-00018
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K100886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2016
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
Was the Report Sent to FDA?
Distributor Facility Aware Date02/18/2016
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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