MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 3 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33650003

Device Problem Osseointegration Problem (3003)

Patient Problems Cyst(s) (1800); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 10/28/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device is not available as it remains in the patient' 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.Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that the patient may need to undergo a revision surgery due to loosening of the tibial component.Surgeon plans to exchange both the tibial component and the talar component.

Manufacturer Narrative

Correction: h6 clinical code.The reported event could be confirmed since images of ct scans were provided and shows loosening of the tibial component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the tibia shows some radiolucence and smaller cysts, there is also a posterior condensation zone.Loosening can be confirmed, but there are no safe signs for migration.¿.Based on investigation, the root cause was attributed to a patient related issue.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.No indications of material, manufacturing or design related problems were found during the investigation.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 may need to undergo a revision surgery due to loosening of the tibial component.Surgeon plans to exchange both the tibial component and the talar component.

• Brand Name: INFINITY TIBIAL TRAY SIZE 3 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: 18188876
• MDR Text Key: 328738524
• Report Number: 3010667733-2023-00703
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122506
• UDI-Public: 00840420122506
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140749
• 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: 01/17/2024

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: 33650003
• Device Lot Number: 1712741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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 Age: 62 YR
• Patient Sex: Male