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

Model Number SEE H10

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 11/02/2018

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 # 3650014, lot 1593472; part # 33630024, lot 1591710; and part # 33654406, lot unknown.Manufacture date for part # 3650014, lot 1593472 is 2/21/2017; manufacture date for 33630024, lot 1591710 is 05/24/2017.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

Allegedly, the surgeon revised the infinity prosthesis as the patient was experiencing lateral pain.Ct scans showed hot spots around the prosthesis showing there to be impingement.Upon visual inspection of post op x-rays the implant according to both surgeons noted the implant to be too lateral.The surgical decision was to remove the original implant, resect more medial mal, and re-implant a size 4 long tibia, 4 talus and 6mm poly.

• 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
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 8144129
• MDR Text Key: 129791374
• Report Number: 1043534-2018-00191
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2018

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: No Information
• Device Model Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention