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

Catalog Number UNK_WWA

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Implant Pain (4561)

Event Date 10/24/2022

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 because the patient was getting some gutter pain/gutter impingement from an oversized talus.

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

The reported event could be confirmed since images of ct scans were provided and matches the alleged failure mode.A medical professional reviewed the received information and noted the following: ¿the ct-scan shows status after primary tar and surgical fusion (that is not naturally occurring as was suggested) of the subtalar and calcaneocuboid joints, and a dwyer osteotomy of the calcaneus.Only the hardware from the dwyer osteotomy is in place.The components of the tar (tibial component, pe-liner, and talar component) are intact.There¿s slight subsidence of the talar component.The talar component looks oversized, causing impingement in the medial and lateral gutters.The reason for revision can be confirmed and is a user-related issue.¿ based on investigation, the root cause was attributed to a user related issue.As noted by a medical professional, ¿the talar component looks oversized, causing impingement in the medial and lateral gutters.¿ 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.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery because the patient was getting some gutter pain/gutter impingement from an oversized talus.

• Brand Name: INFINITY TALAR IMPLANT
• 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: 15814245
• MDR Text Key: 303806405
• Report Number: 3010667733-2022-00391
• 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,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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
• Date Manufacturer Received: 01/17/2023
• 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