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

Device Problem Break (1069)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Literature citation: naghshineh et al.Proximal interphalangeal joint silicone arthroplasty for osteoarthritis: midterm outcomes.Hand.2018; volume 0: 1-5.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 2018 literature article, by naghshineh et al.Titled proximal interphalangeal joint silicone arthroplasty for osteoarthritis: midterm outcomes, the authors describe a 20% revision rate for swanson finger joint arthroplasty of the pip joint.Additionally, the authors present significant rates of complications (37%), implant breakage (12%), instability (12%), chronic pain (9%), and stiffness (5%).

• Brand Name: SWANSON FINGER JOINT
• 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: 8199299
• MDR Text Key: 131496375
• Report Number: 1043534-2018-00204
• 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: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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