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

Catalog Number UNK_WWA

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Subluxation (4525); Insufficient Information (4580)

Event Date 09/01/2022

Event Type  Injury  

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.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.

Manufacturer Narrative

Correction - h6 (clinical code, device code, results code) the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert as below.¿the ct-scan shows an infinity tar implanted, the tibial component looks well placed, following the mechanical axis.The implant-bone interface looks in order.The pe-liner could be well depicted by its negative contrast, in the axial images and looks intact, and not disengaged from the tibial tray.The talar component is well-fixed to the talar bone, however, the component (together with the foot) is subluxated posteriorly relative to the tibial component (including the pe-liner).Without further clinical information, the reason(s) behind this substantial subluxation cannot be assessed.This subluxation is without doubt the reason for the necessary revision.¿ if device is returned or any further information is provided, the investigation report 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 for reasons that are not available at the time of this report.

• Brand Name: INFINITY¿ TOTAL ANKLE SYSTEM
• 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: 15491430
• MDR Text Key: 300637644
• Report Number: 3010667733-2022-00321
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: 01/05/2023
• 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