MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Model Number G4260105

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

Patient Problem Foreign Body Reaction (1868)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, the suspect devices in use are lot # 1620977 and # 1643492.Manufacture date for lot 1620977 is 02/08/2018; manufacture date for lot 1643492 is 12/12/2018.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly the patient underwent a surgical procedure.It was reported that the patient had an infection 6 weeks post op which was treated with iv antibiotics.The symptoms continue to worsen.The surgeon thinks the patient may have an allergic reaction to the implants based on inflammatory markers.

• Brand Name: SWANSON
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• 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: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 8957265
• MDR Text Key: 156728951
• Report Number: 1043534-2019-00120
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2019

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: Health Professional
• Device Model Number: G4260105
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 09/03/2019
• 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): Required Intervention