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

Model Number	NTO156 / CTO09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation related to this event is ongoing.At this time, the available information is insufficient to determine a definitive root cause or whether the device contributed to the reported event.A supplemental mdr will be submitted to fda upon completion of the investigation and when additional information becomes available.
Event or Problem Description
It was reported that a patient underwent a total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2024.Subsequently, the patient reported pain in the metacarpal-internal trapezium area.The patient underwent revision surgery on (b)(6) 2026.An osteophyte was observed, which had not been present at the time of the initial implantation.During the neck revision, the surgeon resected osteophytes and soft tissues, and confirmed that no impingement was present.It was also reported that the cup was still securely in place, with a small trace of metallosis.

• Brand Name: TOUCH - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S / SPHERICAL 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: 25532951
• Report Number: 3024706750-2026-00051
• Device Sequence Number: 9358480
• Product Code: SFA
• UDI-Device Identifier: 07640181160044
• UDI-Public: 07640181160044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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: NTO156 / CTO09
• Device Catalogue Number: NTO156 / CTO09
• Device Lot Number: X7641 / 7839
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 08/07/2026
• 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: 53 YR
• Patient Sex: Male