MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR STEM 10MM LG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 200347901

Device Problems Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Implant Pain (4561)

Event Date 09/10/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient experienced pain and may need to undergo a revision surgery for a talus fracture.

Manufacturer Narrative

The complaint could be confirmed, since the returned image for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: the ct-scan show a small fracture of the posterolateral and inferior side of the talus.To be more precise in the articular surface that is part of the posterior portion of the subtalar joint.The joint shows degenerative changes and sign of osteonecrosis and subchondral cyst formation in the fractured area.These changes are more common in degenerative joints.The implants look intact and well fixed.There are some discrete radiolucencies as mentioned above and i believe they are related to the degenerative changes of the subtalar joint.When looking through the information received, no other irregularities can be found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient experienced pain and may need to undergo a revision surgery for a talus fracture.

• Brand Name: INBONE TALAR STEM 10MM LG
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15543837
• MDR Text Key: 301185702
• Report Number: 3010667733-2022-00335
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797030830
• UDI-Public: 00889797030830
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

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: Lay User/Patient
• Device Model Number: 200347901
• Device Catalogue Number: 200347901
• Device Lot Number: 1681497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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 Outcome(s): Required Intervention