MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S / CONICAL CUP Ø9 MM

Model Number	NTO156 / CTO109
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Codes	Cyst(s) (1800); Metal Related Pathology (4530)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.Based on the available information, the incident is not attributed to a manufacturing or design defect of the specific returned device.After a thorough investigation (returned device, medical imaging, dhr review and complaint history review), the fracture appears to be a multi-factorial event, potential contributing factors include patient-related characteristics, surgical technique, implant positioning, biomechanics and postoperative evolution.In this case, it appears that the most probable root cause of this failure is prosthesis misalignment as reported in the complaint leading to overstress on the component and premature breakage of the component.
Event or Problem Description
It was reported that a patient underwent a total joint arthroplasty of touch cmc1 prosthesis.Subsequently, the patient underwent revision surgery due to off-center positioning of the neck and metallosis, which led to the formation of two cysts.

• Brand Name: TOUCH - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S / 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: 25651954
• Report Number: 3024706750-2026-00057
• Device Sequence Number: 20308998
• Product Code: SFA
• UDI-Device Identifier: 07640181160044
• UDI-Public: 07640181160044
• 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): 06/25/2026

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: NTO156 / CTO109
• Device Catalogue Number: NTO156 / CTO109
• Device Lot Number: X7688 / 8222
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/29/2026
• 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