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

Model Number 33650005

Device Problems Peeled/Delaminated (1454); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

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 total ankle replacement.Sometime post-op the patient was scheduled for an ankle revision.Surgeon was planning on replacing the talar.The surgeon removed talar component and noticed the peeling of the plasma coating.They removed the tibial component and it was the same peeling.

Manufacturer Narrative

The talar dome, talar stem, poly insert and tibial tray 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.Visual examination of all the devices showed a few heavier scratches/dings, which are consistent with removal during the revision surgery.Visual examination the porous surface of the talar dome and tibial tray does exhibit a few areas of apparent bone attachment.Finally, examination of the talar dome and tibial tray found that some of the plasma spray is missing.The device history record was reviewed and indicates that this product was manufactured to specification and met all inspection/acceptance criteria.

• Brand Name: INFINITY 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: 8390138
• MDR Text Key: 137812801
• Report Number: 1043534-2019-00027
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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: Health Professional
• Device Model Number: 33650005
• Device Lot Number: 1579094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 122