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

Model Number SEE D10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

The products were not returned for evaluation.Radiographic images were provided.Review of the images indicates inbone devices in-situ.However, based on the provided images alone, a conclusion cannot be drawn as to why the revision is being performed.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will need to undergo a revision surgery due to soft tissue being weak.The implants look good.

Manufacturer Narrative

H6: the products were not returned for evaluation.Radiographic images were provided.Review of the images indicates inbone devices, medial malleolus plate and screws, and two calcaneal screws in-situ.However, based on the provided images alone, a conclusion cannot be drawn as to why the revision is being performed.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient will need to undergo a revision surgery due to soft tissue being weak.The implants look good.

• Brand Name: INBONE TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11358516
• MDR Text Key: 232830760
• Report Number: 1043534-2021-00031
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE D10
• Device Lot Number: SEE D10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 200009901 LOT 1670788; 200010901 LOTS 1672229 AND 1667976; 200010902 LOT 1672230; 200011901 LOT 1670991; 200347901 LOT 1672091; 220220902 LOT 1649252; 220222903 LOT 1662992; 220223212E LOT 1666128
• Patient Outcome(s): Other; Required Intervention