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

Catalog Number UNK_WWA

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 12/06/2023

Event Type  Injury  

Event Description

It was reported that there is a scheduled revision surgery due to anterior talus subsidence.The plan is to revise the talus only, possibly switching to a flat cut infinity.If necessary, an extended talus plate may be used based on the plan.Additionally, there's a need for a guide for the tibial component if it is loose, considering a switch from infinity to in bone.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.

Manufacturer Narrative

The reported event was confirmed, based on available medical records and assessment of health care professionals.The device inspection was not possible as the product was not returned for investigation.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.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that the tibial component shows some radiolucence.Loosening may be possible, and migration could not be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows radiolucency and subsidence, hence loosening and migration can be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence around tibial components and subsidence of talar component.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that there is a scheduled revision surgery due to anterior talus subsidence.The plan is to revise the talus only, possibly switching to a flat cut infinity.If necessary, an extended talus plate may be used based on the plan.Additionally, there's a need for a guide for the tibial component if it is loose, considering a switch from infinity to inbone.

• Brand Name: UNKNOWN TALAR COMPONENT
• 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: 18415841
• MDR Text Key: 331577486
• Report Number: 3010667733-2023-00820
• 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: 02/28/2024

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: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/28/2024
• 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): Required Intervention
• Patient Sex: Female