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

Catalog Number 22022XXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Allegedly per (b)(6) et.Al.2014, "intraoperative and perioperative complications during revision arthroplasty for salvage of a failed total ankle arthroplasty." a retrospective of 35 cases of failed agility taa revised to an inbone ii taa was performed at 1 institution.Which showed that there were 6 intraoperative and 5 acute postoperative complications, leading to an overall 31.4% complication rate.There was 1 patient with continued pain postoperatively who underwent a second revision of the inbone ii 20 months postoperatively.

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.The event device code is addressed in the package insert.This report will be updated when the investigation is complete.

• Brand Name: INBONE II
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; arlington TN
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd.; arlington TN 38002
• Manufacturer Contact: amanda clark ; 1023 cherry rd.; memphis, TN 38112 ; 9018674140
• MDR Report Key: 4264833
• MDR Text Key: 5003306
• Report Number: 1043534-2014-00167
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 22022XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 10/31/2014
• 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