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

Model Number	NTO156
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/27/2026
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 touch cmc1 revision surgery on (b)(6) 2026, due to dislocation and defective pe liner.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: h6, h11.The reported event could be confirmed since the affected device was returned for investigation.Potential contributing factors include patient-related characteristics such as patient anatomy and laxity, surgery-related considerations including implant sizing and alignment, and external factors such as trauma and early post-operative activity.This event is a known clinical complication described in the device's instructions for use (ifu).Based on the available information, no evidence of a design or manufacturing defect was identified.

• Brand Name: TOUCH - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S
• 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: 25607932
• Report Number: 3024706750-2026-00054
• Device Sequence Number: 9922795
• Product Code: SFA
• UDI-Device Identifier: 07640181160044
• UDI-Public: 07640181160044
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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
• Device Catalogue Number: NTO156
• Device Lot Number: X6511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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 Sex: Unknown