MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED,

Model Number 33630022

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

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 01/03/2017

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

Allegedly, it was reported that the patient was scheduled for a calcaneal osteotomy.It was reported that during incision, it was discovered the patient could possibly have an infection.Tissue cultures confirmed the infection, so all of the ankle replacement implants were removed from the patient.The implant appeared to "stuck" to the patient's bone.Therefore, the bone was peeled off of the talus and tibial components.Surgeon created an antibiotic cement spacer.No additional patient complications were reported.

Manufacturer Narrative

The parts were returned for evaluation.Overall, the poly insert and tibial tray did not show any gross deformation.Visual examination of all the devices 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 talar dome and tibial tray does exhibit a few areas of apparent bone attachment.Finally, examination of the talar dome found that some of the plasma spray is missing.

• Brand Name: INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED,
• 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: tim nickel ; 1023 cherry road; memphis, TN 38117 ; 901451-631
• MDR Report Key: 6258569
• MDR Text Key: 65028989
• Report Number: 1043534-2017-00004
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 33630022
• Device Lot Number: 1556327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/04/2017
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention