MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 8MM - M

Model Number	NTO08
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Joint Impingement (4834)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigations.A review of the device history record for the reported lot did not indicate any abnormalities related to the reported event.After a thorough investigation (medical imaging, returned device, device history record review, complaint history review), it appears that the pe liner deformation is most likely related to patient related factors (bone regrowth leading to impingement), and/or insufficient bone resection leading to bone impingement rather than a device problem.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.
Event or Problem Description
It was reported that a 60-year-old male patient underwent a revision surgery of touch cmc1 prosthesis on (b)(6) 2026, 6 months after the initial implantation, due to crepitation that had developed.During the procedure, the surgeon replaced the neck component.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 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: 24557557
• Report Number: 3024706750-2026-00011
• Device Sequence Number: 9531795
• Product Code: SFA
• UDI-Device Identifier: 07640181160020
• UDI-Public: 07640181160020
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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
• Device Model Number: NTO08
• Device Catalogue Number: NTO08
• Device Lot Number: 8404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2024
• 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: 60 YR
• Patient Sex: Male