MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ BIOFOAM¿ 3D; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680033

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that a crack in the anterior lateral talar peg was found at the patient's 11 month (approx) follow up.No revision has been scheduled at this time.

Manufacturer Narrative

The reported event could be confirmed, since one radiographic image was provided evaluation and matches the alleged failure.The device inspection revealed the following: from review of the image it appears the talar dome has fractured and migrated posteriorly.Based on the image alone, the reason for implant breakage could not be determined.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that a crack in the anterior lateral talar peg was found at the patient's 11 month (approx) follow up.No revision has been scheduled at this time.

• Brand Name: INFINITY¿ BIOFOAM¿ 3D
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12470853
• MDR Text Key: 271536839
• Report Number: 0001043534-2021-00180
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073073
• UDI-Public: 00889797073073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33680033
• Device Catalogue Number: 33680033
• Device Lot Number: 1686956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2020
• 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 Age: 64 YR
• Patient Sex: Male