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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

The device was not returned.Films were supplied which show lucent at the area of the anterior tibial collapse.

Event Description

Allegedly, the patient underwent a total ankle replacement.The patient was doing well post op.He was weight bearing and in regular shoes.Went back to work and light exercise.The surgeon noticed a slight slope of tibial tray on first weight bearing xray but the patient did not complain of pain.Follow up xrays showed no change in alignment.The surgeon reviewed the prior films noticed a lucency at area of anterior tibial collapse looks like a pin site.Patient underwent a revision surgery with invision, the tibia was fixed when impacting.

• Brand Name: INFINITY(R)
• 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: 7691933
• MDR Text Key: 114136014
• Report Number: 1043534-2018-00064
• 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: health professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 111