MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM

Model Number	TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
Medical Device Problem Codes	Biocompatibility (2886); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned for investigations.Following investigation including dhr verification and x-ray analysis it appears that the patient prematurely overloaded the implant, with immobilization lasting only seven days, which prevented proper cup osseointegration.Following the revision surgery, one hypothesis is that the defect may have also occurred during the reaming step, possibly due to excessive speed leading to overheating.The most probable root cause identified for this event is a user error.This identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
The patient, a 62-year-old male with a manual/physical occupation, reported the onset of pain in july without any identified triggering factor, despite doing well between march and may 2025.Immobilization was maintained for 7 days.He underwent a revision surgery on (b)(6) 2025 leading to trapeziectomy.
Additional Manufacturer Narrative
The positive nickel allergy test provides a plausible explanation for the implant migration and the pain experienced by the patient, suggesting that an allergic reaction may have contributed to the clinical outcome.This follow report is been submitted to relay additional information.The following sections have been updated: b6, h6, h11.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
• Manufacturer (Section D): KERI MEDICAL SA; 5 chemin du pre-fleuri; plan-les-ouates, 1228 ; SZ 1228
• Manufacturer (Section G): KERI MEDICAL FRANCE; 34 rue antoine redier; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; 5 chemin du pre-fleuri; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 23520961
• Report Number: 3024706750-2025-00013
• Device Sequence Number: 13187956
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
• Device Catalogue Number: CTO109
• Device Lot Number: 8606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2024
• 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: 62 YR
• Patient Sex: Male