MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE 1 TAR; TOTAL ANKLE REPLACEMENT

Catalog Number 200X-XXXX

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Allegedly per "modular stem-fixed bearing total ankle replacement" prospective results of 23 consecutive cases with 3 year follow-up" (brigido 2014), a total of 2 minor complications (8.6%) occurred; 1 pt (4.3%) experienced stiffness, and 1 (4.3%) pt developed a superficial infection.No intraoperative fractures, postoperative fractures, or tibial loosening occurred.A total of 7 major complications (30.3%) developed; 2 patients (8.7%) had major wounds, 1 (4.3%) required a local pedicle flap (anterior thigh), 1 (4.3%) was treated with a free flap (local rotational flap), 1 (4.3%) developed a deep infection, requiring revision, and 2 (8.7%) experienced a pulmonary embolism.One pt (4.3%) presented with ectopic bone formation and underwent removal without complications.One pt (4.3%) demonstrated talar subsidence at the 3 year eval.No deep venous thrombosis developed, and no tendon or nerve injuries occurred.

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.The event device code is addressed in the package insert.This report will be updated when the investigation is complete.

• Brand Name: INBONE 1 TAR
• Type of Device: TOTAL ANKLE REPLACEMENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; arlington TN
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: amanda clark ; 1023 cherry rd; memphis, TN 38117 ; 9018674140
• MDR Report Key: 4170272
• MDR Text Key: 5024504
• Report Number: 1043534-2014-00159
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 200X-XXXX
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other