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

Device Problem Fracture (1260)

Patient Problem Rheumatoid Arthritis (1724)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

Literature citation: taniguchi et al.Recurrence of deformity after silicone implant and resection arthroplasty of the metatarsophalangeal joint for rheumatoid arthritis: long-term results.Modern rheumatology.27:2, 266-270.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 an article by taniguchi et al, titled "recurrence of deformity after silicone implant and resection arthroplasty of the metatarsophalangeal joint for rheumatoid arthritis: long-term results" the authors describe the implant integrity at final follow-up as "deformation or suspected fragmentation" in 9 feet and "visible fracture of the stem or the hinge" in 2 feet.

• 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: 8388231
• MDR Text Key: 137784407
• Report Number: 1043534-2019-00022
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K780132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/03/2019
• Initial Date FDA Received: 03/04/2019
• 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