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

Catalog Number UNK_WWA

Device Problems Inadequacy of Device Shape and/or Size (1583); Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 04/12/2023

Event Type  Injury  

Event Description

There is an upcoming revision surgery.The surgeon is most likely going to replace only the talar component with an inbone talus.Downsized due to gutter impingement.The surgeon does not think that he will need to change out the tibia.The revision is due to pain/stiffness/impingement and talar loosening.Also there is a medial mal stress fx.

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.Device disposition is unknown.

Manufacturer Narrative

Please note the corrections made to the h6 device code and the clinical signs code: the reported event was confirmed, since evaluation of the provided imaging does indicate the likely need for a revision surgery.Upon further investigation of the ct scans by healthcare professionals the following was observed, some of the problems are likely to be user related, as impingement might be caused by the selection of the talar components size.There is not too much to see with regards to loosening for the tibia, which is in line with the surgeons statement.The talar component does not show clear signs of loosening or migration, however there are conflicts visible specifically with the medial malleolus of the tibia.That seems to be the reason for the revision.No clear signs of loosening, migration, infection or breakage.Some conflict of the talar component with the surrounding tissue." based on the investigation, the root cause can be attributed to a combination of the patient and user related issue.There are conflicts visible with the medial malleoulus and tibia that could be the result of the talar size selected in the primary surgery.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

There is an upcoming revision surgery.The surgeon is most likely going to replace only the talar component with an inbone talus.Downsized due to gutter impingement.The surgeon does not think that he will need to change out the tibia.The revision is due to pain/stiffness/impingement and talar loosening.Also there is a medial mal stress fx.

• 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: 16911958
• MDR Text Key: 315009226
• Report Number: 3010667733-2023-00250
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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: 09/19/2023
• 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): Other