MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 2S; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number	G4260102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned as it remains implanted in the patient.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient may be having an allergic reaction to the implant.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.During the investigation, it was determined that the primary material of the device is silicone elastomer, with the grommets being manufactured from unalloyed titanium.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use were reviewed and states: "in using joint prostheses, the surgeon should be aware all products are manufactured from silicone elastomer, except the finger, toe, and wrist grommets, which are manufactured from titanium" and "the risks and complications with silicone implants include allergic reaction(s) to prosthesis material(s)." no indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient may be having an allergic reaction to the implant.

• Brand Name: FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 2S
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19746597
• Report Number: 3010667733-2024-00439
• Device Sequence Number: 15099615
• Product Code: KWH
• UDI-Device Identifier: 00840420127471
• UDI-Public: 00840420127471
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K780132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: G4260102
• Device Lot Number: 1771214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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: Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female