MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH CMC 1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM

Model Number	TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is a 60-year-old active male (dob: (b)(6) 1965, weight unknown) who underwent surgery on (b)(6) 2025, during which bone grafts were required to place the cup due to a cyst; postoperative immobilisation was planned for 4 weeks but was discontinued by mistake after 7 days.At a standard postoperative control visit, the patient reported no pain or dysfunction but x-rays showed cup migration and trapezium fracture.On (b)(6) 2025, a revision surgery was performed with the sales representative present; no metallosis was observed, the cup had migrated from the trapezium into the surrounding tissue, and the trapezium was fractured in the middle, preventing placement of a new cup.
Additional Manufacturer Narrative
Material analysis (visual, functional and dimensional inspections) could not be confirmed, since the affected device was not returned.The device and the complaint history review could not be performed as the device lot details were not provided.Based on the provided medical imaging, the failure appears to be primarily related to inadequate bone quality and quantity (small trapezium), which constitutes a contraindication to implantation.The patient did not comply with postoperative recommendations, as immobilization - originally prescribed for four weeks - was discontinued after only seven days.This premature discontinuation likely contributed to impaired osseointegration.

• Brand Name: TOUCH CMC 1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
• Manufacturer (Section D): KERI MEDICAL SA; 5 chemin du pre-fleuri; plan les ouates, che 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: 23497041
• Report Number: 3024706750-2025-00003
• Device Sequence Number: 12976339
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
• Device Catalogue Number: CTO109
• 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: 08/12/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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 Age: 60 YR
• Patient Sex: Male