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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ossification (1428); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Literature citation: mark a.Prissel (et al.A review of 399 total ankle replacements: analysis of ipsilateral subtalar joint arthrodesis and associated talar component subsidence.The journal of foot and ankle surgery.2017; 56: 10-14.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, per prissel 2017 et al, "a review of 399 total ankle replacements: analysis of ipsilateral subtalar joint arthrodesis and associated talar component subsidence", it was reported that 5 total ankle replacement cases required a revision of the talar component.The five primary reported modes of failure were talar subsidence in 2 patients, gutter impingement in 1 patient, osteolysis of the talus in 1 patient and heterotropic ossification in 1 patient.The mean time to failure was 25.8 months.

• Brand Name: INBONE® I
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: timothy nickel ; 1023 cherry road; 901451-631
• MDR Report Key: 6331797
• MDR Text Key: 67482464
• Report Number: 1043534-2017-00020
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• 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: 01/24/2017

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
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention