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

Model Number	NTO08
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Mechanical Jam (2983)
Health Effect - Clinical Codes	Implant Pain (4561); Joint Impingement (4834)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.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 (returned device, device history record review, complaint history review), it appears that the failure was most likely due to the patient's anatomical characteristics and/or implant initial positioning causing initial intra-prosthetic conflict and leading to pe liner blockage and dislocation.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 patient underwent total joint arthroplasty on an unknown date.Subsequently, on (b)(6) 2026, the patient underwent a revision for unknown reasons.No further event information was available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b5, b6, d6a, h6, h11.Based on the additional clinical information provided by the surgeon, the most probable root cause of the event remains a combination of the patient's anatomical characteristics; specifically, bone impingement due to a small trapezium, and the initial implant positioning (cup mispositioning).When combined with the reported traumatic workplace incident involving axial impact to the thumb, these factors likely contributed to an intra-prosthetic conflict, resulting in polyethylene (pe) liner blockage and subsequent dislocation.
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty on (b)(6) 2025.Subsequently, on (b)(6) 2026, the patient underwent a revision due to a workplace accident, involving an axial impact to the thumb, followed by a locking sensation with inability to mobilize the joint and associated pain.During the revision procedure, in addition to replacing the liner, the surgeon performed slight osteophyte reduction.

• 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: 24345203
• Report Number: 3024706750-2026-00004
• Device Sequence Number: 15953751
• Product Code: SFA
• UDI-Device Identifier: 07640181160020
• UDI-Public: 07640181160020
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• 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
• Operator of Device: Health Professional
• Device Model Number: NTO08
• Device Catalogue Number: NTO08
• Device Lot Number: X7797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: 59 YR
• Patient Sex: Female