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

Model Number 33650004

Device Problem Material Disintegration (1177)

Patient Problem Injury (2348)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

The device has 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 total ankle replacement; placement of cement spacer.The tibial component showed delamination of the plasma spray.No additional information is available at this time.

Manufacturer Narrative

The tibial tray was returned for evaluation.Visual examination of the device showed a few gouge marks and heavier scratches/dings, which are consistent with removal during the revision surgery.Visual examination the porous surface of the tibial tray does exhibit a few areas of apparent bone attachment.Finally, examination of the tibial tray found that some of the plasma spray is missing.Boney ingrowth was evident on areas of the remaining porous coating.Energy dispersive spectroscopy was used to perform elemental analyses.The elements identified indicated that the substrate was manufactured from ti-6al-4v and that the plasma sprayed coating was manufactured from commercially pure titanium.An x-ray map was acquired to show the attachment points of the titanium plasma sprayed coating to the ti-6al-4v substrate.

• Brand Name: INFINITY®
• 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: 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7568773
• MDR Text Key: 110053236
• Report Number: 1043534-2018-00043
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: Other
• Device Expiration Date: 11/06/2023
• Device Model Number: 33650004
• Device Lot Number: 1569233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention