MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON FLEXIBLE HINGE TOE WITH GROMMETS; SMALL JOINT COMPONENT

Catalog Number G426-0101

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 06/16/2015

Event Type  Injury  

Event Description

Allegedly, surgery was done on a patient and swanson implant was put in the patients 1st mpj joint.The doctor believes that the patient is having an allergic reaction to the implant.

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.

• Brand Name: SWANSON FLEXIBLE HINGE TOE WITH GROMMETS
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901867-414
• MDR Report Key: 4920161
• MDR Text Key: 19641303
• Report Number: 1043534-2015-00041
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: G426-0101
• Device Lot Number: 1561290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• 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 Age: 49 YR