MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 1S; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number G4260101

Device Problems Break (1069); Degraded (1153); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that the patient stubbed their toe 3 months post-op causing the implant to fail, degrading and breaking laterally.The patient underwent a revision surgery 5 months post-op.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

• Brand Name: FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 1S
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19093329
• MDR Text Key: 339981619
• Report Number: 3010667733-2024-00203
• Device Sequence Number: 1
• Product Code: KWH
• UDI-Device Identifier: 00840420127464
• UDI-Public: 00840420127464
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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: Lay User/Patient
• Device Catalogue Number: G4260101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 63 YR
• Patient Sex: Female