MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INFINITY TALAR DOME; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problem Off-Label Use (1494)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/19/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery.The patient has a size 3 tibial tray and a size four talar dome.This is most likely the mechanism of failure, as that construct is not a design possibility.

Manufacturer Narrative

The reported event could be confirmed with review of available ct imaging by a medical professional.Upon further investigation of the ct scans by healthcare professionals the following was observed, ¿the talus shows radiolucence and small cavities.There is loosening visible, but no clear migration.The talar component seems to be chosen one size larger than the tibial one.However, the talar component has to be the same size or one size smaller than the tibial one and the revising surgeon suspects, that the selection of the wrong implant size may have contributed to the failure.*therefore, it is questionable whether the device was used as intended." based on investigation, the root cause was attributed to a user related issue.The event was caused by the initial treating surgeon choosing a size combination of the tibial tray and talar component that is not recommended and can lead to the complications seen in this particular situation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device remains implanted in patient.

• Brand Name: UNKNOWN INFINITY TALAR DOME
• 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: 18431658
• MDR Text Key: 331862553
• Report Number: 3010667733-2024-00001
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2024

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• 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): Other
• Patient Sex: Male