MAUDE Adverse Event Report: KERI MEDICAL SA Touch - CMC1 Prosthesis; TOUCH® - CMC1 Prosthesis Offset Neck 15° - 8mm - M / Spherical Cup Ø9 mm

Model Number	NTO158 / CTO09
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male 68-year-old patient, underwent for surgery on (b)(6) 2022.Since march, he reported recurrent pain for the first time.The surgeon decided to perform a revision surgery, explanted the prosthesis, and proceeded with a trapeziectomy.
Additional Manufacturer Narrative
Based on the available information, the incident is not attributed to a manufacturing or design defect of the specific returned device.Based on the available information, the root cause of the reported event could not be determined with certainty.The explant findings are consistent with an intra prosthetic conflict, potentially resulting from a deviation from the surgical technique and possibly exacerbated by the patient's high level of activity.However, the initiating mechanism that led to the development of this intra prosthetic conflict could not be conclusively established.

• Brand Name: Touch - CMC1 Prosthesis
• Common Device Name: TOUCH® - CMC1 Prosthesis Offset Neck 15° - 8mm - M / 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: 50015459
• Report Number: 3024706750-2026-00080
• Device Sequence Number: 10551220
• Product Code: SFA
• UDI-Device Identifier: 07640181160051
• UDI-Public: 07640181160051
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NTO158 / CTO09
• Device Catalogue Number: NTO158 / CTO09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/27/2026
• 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: 68 YR
• Patient Sex: Male