MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM

Model Number	CTO109
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty of touch cmc1 on (b)(6) 2025.Subsequently, the patient underwent a revision on (b)(6) 2026 due to cup malpositioning.The surgeon replaced the device with a 9mm conical cup, and a new hole was excavated beside the original one, bordered by a circular arrangement of bones.
Additional Manufacturer Narrative
Based on the information currently available (including device history record review, complaint history assessment, and surgeon assessment), the event appears to be primarily related to a cup malposition which led to mechanical stress on the prosthesis.If additional information is made available, the investigation will be updated as applicable and supplemental mdr will be submitted.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
• 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 ; chemin du pre-fleuri 5; plan-les-ouates 1228
• MDR Report Key: 24616280
• Report Number: 3024706750-2026-00019
• Device Sequence Number: 10333854
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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 Model Number: CTO109
• Device Catalogue Number: CTO109
• Device Lot Number: 9899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG