MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH - CMC1 PROSTHESIS; TOUCH - CMC1 PROSTHESIS CONICAL CUP Ø9 MM

Model Number	CTO109
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total joint arthroplasty with a touch cmc1 prosthesis approximately 2 years ago.Subsequently, the patient underwent revision surgery on (b)(6) 2026, following detection of aseptic cup loosening.The surgeon reported that he believed the cup never osseointegrated in the trapezium.During the revision surgery, the cup and neck components were removed, and the surgeon proceeded with a trapeziectomy.
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.After a thorough investigation (returned device, dhr review and complaint history review), the reason for the aseptic loosening of the cup, 2 years post-implantation, remains unclear.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: TOUCH - CMC1 PROSTHESIS
• Common Device Name: TOUCH - CMC1 PROSTHESIS CONICAL CUP Ø9 MM
• Manufacturer (Section D): KERI MEDICAL SA; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• Manufacturer (Section G): KERI MEDICAL FRANCE; 34 rue antoine redier; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 25277499
• Report Number: 3024706750-2026-00040
• Device Sequence Number: 18431208
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: Health Professional
• Device Model Number: CTO109
• Device Catalogue Number: CTO109
• Device Lot Number: 7472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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 Sex: Unknown