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

Catalog Number UNK_WWA

Device Problems Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Insufficient Information (4580)

Event Date 03/19/2024

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery for reasons that are not available at the time of this report.

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 not be confirmed based on available medical record and medical expert assessment.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Failure of total ankle replacement (tar) over time is a known complication.In case of a planned revision procedure a medical opinion is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a proper full clinical assessment and to identify possible causes of failure.In cases where a ct scan is the only available clinical source the informative value and the assessment of the underlying potential cause of a failure is severely limited.In the vast majority of these cases no conclusive statement can be provided, because the accompanying clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient) is missing.Radiographic findings such as radiolucent areas and bone cysts may indicate potential problems, but their clinical significance remains uncertain without the additional context.Due to the limited information and clinical context, we therefore refrain from making definitive statements about the patient, the procedure and/or the device in relation to the failure.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿no conclusive statement can be provided.There is some radiolucence and some cysts visible at the anterior tibial component.The talar implant shows little radiolucence as well.There is no clear statement possible regarding loosening or migration of the components without further clinical information and no conclusive statement can be given without further clinical information regarding the underlying cause or the relation to the device in this case.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.According to the hcp, there is some radiolucence and cysts visible at the anterior tibial component.There is also some radiolucence around the talar component.But no clear statement is possible regarding loosening or migration of the components and without further clinical information, no conclusive statement can be given regarding the underlying cause or the relation to the device in this case.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery for reasons that are not available at the time of this report.

• Brand Name: UNKNOWN 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: 19098164
• MDR Text Key: 340042340
• Report Number: 3010667733-2024-00205
• 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: 05/31/2024

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: 03/19/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• 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: Female