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

Device Problem Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Literature citation: chung et al.A multicenter clinical trial in rheumatoid arthritis comparing silicone metacarpophalangeal joint arthroplasty with medical treatment.Jhs.2009; volume 34: page(s) 815-823.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, in a 2009 literature article, by chung et al.Titled a multicenter clinical trial in rheumatoid arthritis comparing silicone metacarpophalangeal joint arthroplasty with medical treatment, the authors mention 2 revisions of mcp arthroplasty with swanson finger implants, one due to recurrence of ulnar drift and another due to dislocation.

• Brand Name: SWANSON
• Type of Device: PROSTHESIS, FINGER, 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: 8197587
• MDR Text Key: 131441104
• Report Number: 1043534-2018-00199
• Device Sequence Number: 1
• Product Code: KWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention