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.

Manufacturer Narrative

The talar dome, talar stem and poly insert were returned for evaluation.Overall, the poly insert did not show any gross deformation.The talar dome and talar stem were returned still seated together with some bone cement covering approximately half of the porous surface.Visual examination of all the devices showed a few heavier scratches/dings, which are consistent with removal during the revision surgery.Finally, examination of the talar dome found that some of the plasma spray is missing.

• 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
• 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
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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
• Event Location: Hospital
• Date Manufacturer Received: 12/17/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR