MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 8MM - M

Model Number	NTO158
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2025.Subsequently, the patient alleged pain and underwent a revision surgery on (b)(6) 2025.Revision surgery revealed a pe liner breakage.
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.Poor bone preparation leading to a misaligned cup and a slightly misaligned stem are possible contributing factors to the device's breakage.In addition, the patient's young age and high physical activity level as a firefighter likely subjected the prosthesis to increased mechanical stress, further contributing to the failure.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 8MM - M
• 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: 24866094
• Report Number: 3024706750-2026-00026
• Device Sequence Number: 9271358
• Product Code: SFA
• UDI-Device Identifier: 07640181160051
• UDI-Public: 07640181160051
• 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: 2025
• 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): 04/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NTO158
• Device Catalogue Number: NTO158
• Device Lot Number: X8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2025
• 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: 43 YR
• Patient Sex: Male