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

Catalog Number 20022XXXXX

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Radiation Overexposure (3017)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

The investigation is not complete, trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2016-00067, 00069.

Event Description

Allegedly, per roukis et al 2016 interoperative radiation exposure during revision total ankle replacement, there were two talar domes and polys revised due to talar loosening and osteolysis.There were eight intraoperative fractures in revisions.Seven of eight were malleolar fractures and one of eight was a talar body fracture.This was noted as a possible result of the limited stability the external guidance jig provided with large osseous voids and thin malleoli due to revision.These occurred while the jig was attached to the patient.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: INBONE I POLY
• 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 ; 901451-631
• MDR Report Key: 5804421
• MDR Text Key: 49878866
• Report Number: 1043534-2016-00068
• 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,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20022XXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1