MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® CMC 1 Prosthesis; joint replacement, finger

Catalog Number	CTO109, NTO1510
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision due to infection.The patient presented redness of skin, pain and swelling approximately two week post implantation.
Additional Manufacturer Narrative
This is a follow-up report to correct an error in the importer report number.

• Brand Name: TOUCH® CMC 1 Prosthesis
• Common Device Name: joint replacement, finger
• Manufacturer (Section D): KERI MEDICAL SA; chemin du pre-fleuri 5; geneva, plan-les-ouates 1228 ; SZ 1228
• MDR Report Key: 50195147
• Report Number: 50195147
• Device Sequence Number: 6111102
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026
• Report Date (Section F): 08/10/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CTO109, NTO1510
• Device Lot Number: 10076, 9568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/10/2026