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

Model Number SEE H10

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device. However, the suspect devices in use are part # 220220902, lot # 1466363; part # 220222206e, lot # 1475773; and part # 20034790x. The implants have been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.

Event Description

Allegedly, the patient underwent a revision of total ankle. Upon explantation of the talar dome it was noticed that the plasma coating had chipped off under the surface. The patient was not adversely affected and the surgical case was not compromised in any way. Invision revision talar plate and talar dome were used as planned in the revision. Original ankle in patient for over a year.

• Brand Name: INBONE TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 8479855
• MDR Text Key: 140817653
• Report Number: 1043534-2019-00047
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/03/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: SEE H10
• Device LOT Number: SEE H10
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 04/03/2019 Patient Sequence Number: 1