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

Catalog Number	CTO109,NTO08,STO1
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2026.Intraoperatively she showed signs of soft bone, the cup after impaction immediately subsided and rotated ulnar.Subsequently, during the 6-wk follow-up it was discovered the trapezium has fractured causing the implant to fail; the radial side of the trapezium fractured, and the cup has dislodged.Reported patient limited function, no trauma was reported.The patient underwent a revision surgery on (b)(6) 2026, the neck and cup were explanted, and the surgeon performed a suspensionplasty.
Additional Manufacturer Narrative
All information reasonably known to the importer is included in this report.

• 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: 25073388
• Report Number: 3009540749-2026-00001
• Device Sequence Number: 21506672
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026
• Report Date (Section F): 05/04/2026

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,NTO08,STO1
• Device Lot Number: 9237, 9359, 9142
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• 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 Sex: Female
• Date Report Sent to FDA: 05/04/2026