MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® CMC 1 PROSTHESIS; JOINT REPLACEMENT, FINGER

Catalog Number	NTO08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All information reasonbly known to the importer is included in this report.
Event or Problem Description
I was reported that two weeks post revision, the patient lifted his grandchild and the device dislocated.The surgeon performed a closed reduction at his under fluoroscopy; however, the patient reported that the device felt unstable and was "popping out." the surgeon noted that the patient was not compliant with activity restrictions (e.G., vacuuming, tae-kwon-do arm stretches) and had removed the post-initial implantation soft wrap prematurely.The surgeon decided to perform a revision and observed laxity in the joint space, but he confirmed that both the cup and the stem were stable.

• 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: 25522990
• Report Number: 3009540749-2026-00003
• Device Sequence Number: 16103821
• Product Code: SFA
• UDI-Device Identifier: 07640181160020
• UDI-Public: 07640181160020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2026
• Report Date (Section F): 06/16/2026

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: NTO08
• Device Lot Number: 9359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 06/16/2026