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

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

Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will undergo a revision surgery.

Manufacturer Narrative

H3: visual examination of the devices shows scratches and staining consistent with implant and subsequent removal of the devices.The plasma spray coating also is worn on the superior anterior side of the tibial tray around the pegs.Previous test reports on this issue indicates this most likely occurs during removal.There is evidence of calcification on the tibial tray and talar dome.The plasma spray coating is also missing from the inferior side of the talar dome around one peg and toward the posterior of the same side.The poly exhibits scratches and deformation consistent with removal techniques.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will undergo a revision surgery.

• 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: 10195993
• MDR Text Key: 197603873
• Report Number: 1043534-2020-00129
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLY INSERT; TALAR DOME SIZE 2; TIBIAL TRAY
• Patient Outcome(s): Required Intervention