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

Catalog Number	G4260001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "on removal it was noticed that the device was broken.It was torn down one side.Patient experienced severe pain in the joint, requiring high doses of analgesia, intense physio and a diagnosis of complex regional pain syndrome (crps).Joint swelling constantly and patient was in constant pain.Because of severe pain, patient was investigated for osteomyelitis.This defect was not picked up on magnetic resonance imaging (mri) or x-rays.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that "on removal it was noticed that the device was broken.It was torn down one side.Patient experienced severe pain in the joint, requiring high doses of analgesia, intense physio and a diagnosis of complex regional pain syndrome (crps).Joint swelling constantly and patient was in constant pain.Because of severe pain, patient was investigated for osteomyelitis.This defect was not picked up on magnetic resonance imaging (mri) or x-rays.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the shared picture evidence confirms the issue.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 1
• Common Device Name: 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24333114
• Report Number: 3010667733-2026-00119
• Device Sequence Number: 21279697
• Product Code: KWH
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K780132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: G4260001
• Device Lot Number: 1728394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 171 LB