MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH - CMC1 PROSTHESIS CONICAL CUP Ø9 MM / STRAIGHT NECK 0° - 8MM - M

Model Number	CTO109
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	04/08/2026
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 a total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2026.Intraoperatively she showed signs of soft bone, the cup after impaction immediately subsided and rotated ulnar; it remained stable through range of motion and did not dislocate.Subsequently, during the 6 week follow-up it was discovered the trapezium has fractured causing the implant to fail; the radial side of the trapezium fractured and the cup has dislodged.Reported patient limited function, no trauma was reported the patient underwent a revision surgery on (b)(6) 2026, the neck and cup were explanted and the surgeon performed a suspensionplasty.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b6, d9, h3, h6, h11.The reported event could be confirmed since the affected device was returned for investigation.After a thorough investigation (medical imaging, returned device, dhr review, complaint history review), the most probable root cause of the migration of the cup is related to poor bone quality, which is a contraindication.As outlined in the device instructions for use (ifu), implantation of the touch device is contraindicated in cases of poor bone quality that may preclude adequate fixation, as well as in cases where patient bone dimensions are incompatible with the available implant sizes.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 CONICAL CUP Ø9 MM / STRAIGHT NECK 0° - 8MM - M
• Common Device Name: TOUCH - CMC1 PROSTHESIS
• 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: 25112099
• Report Number: 3024706750-2026-00035
• Device Sequence Number: 10347247
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: CTO109
• Device Catalogue Number: CTO109
• Device Lot Number: 9237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2025
• 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: 72 YR
• Patient Sex: Female