MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 2 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 220220902

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that patient will need to undergo a revision surgery due to some subsidence of the talus.

Manufacturer Narrative

The device is not available for evaluation as it remains in the patient.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.

Event Description

It was reported that patient will need to undergo a revision surgery due to some subsidence of the talus.

Manufacturer Narrative

Correction b2, 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 of this case shows the tracks of an earlier trans-articular ankle nail which has been removed before the index surgery.At the time the tract was filled with bone cement, which also has been removed.The tibial inbone component has a sclerotic line and a thin radiolucent area surrounding it, the latter can be an image artifact, but is may also be indicative as an early sign of loosening.The tibial tray looks well-fixed, however.The pe-liner looks intact, yet a retrieval is necessary for definitive conclusions.The talar component has subsided, most likely due to the poorer quality of the talar bone after the earlier surgery.More clinical information is needed to assess the root cause (indication for revision), because amongst others, a low-grade infection could play a role in this case.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

Manufacturer Narrative

Correction: d1, h6 results code the reported event that was alleged of issue ¿implant - migration¿ could be confirmed, since information and images of the rep confirm the device was explanted.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.No indications of material, manufacturing or design related problems were found during the investigation.Formal medical opinion was sought from an experienced independent medical expert as below.¿the ct scan of this case shows the tracks of an earlier trans-articular ankle nail which has been removed before the index surgery.At the time the tract was filled with bone cement, which also has been removed.The tibial inbone component has a sclerotic line and a thin radiolucent area surrounding it, the latter can be an image artifact, but is may also be indicative as an early sign of loosening.The tibial tray looks well-fixed, however.The pe-liner looks intact, yet a retrieval is necessary for definitive conclusions.The talar component has subsided, most likely due to the poorer quality of the talar bone after the earlier surgery.More clinical information is needed to assess the root cause (indication for revision), because amongst others, a low-grade infection could play a role in this case.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that patient will need to undergo a revision surgery due to some subsidence of the talus.

• Brand Name: INBONE TALAR DOME SZ 2 SULCUS
• 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: 15326829
• MDR Text Key: 298956845
• Report Number: 3010667733-2022-00292
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420124210
• UDI-Public: 00840420124210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100886
• 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,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 220220902
• Device Catalogue Number: 220220902
• Device Lot Number: 1625110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female