MAUDE Adverse Event Report: KERI MEDICAL SA Touch - CMC1 Prosthesis; TOUCH® - CMC1 Prosthesis Conical Cup Ø9 mm

Model Number	CTO109
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury

• 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 reider; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 50821128
• Report Number: 3024706750-2026-00098
• Device Sequence Number: 16114310
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/15/2026

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: 8832
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 63 YR
• Patient Sex: Male