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 Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Wound Infection (2447); Skin Infection (4544)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device was not returned for investigation and batch number was not provided.According to the surgeon, it is a wound infection that became deep infection, with staphylococcus aureus on all samples sent to anapath.The most probable root cause of this event is an infection not related to the device.The incident is attributable to patient-related factors / surgery procedure, rather than a device-related issue.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was reported that after following surgical post op instructions, the surgical dressings have been removed.The patient noted unusual coloring of the surgical site and returned to the hospital for the wound to be checked.Following an x-ray of the hand, the surgical team identified abnormal tissue growth around the implants.The patient was brought back to the hospital for a secondary procedure where the implants were removed and the surgical site was cleaned.The implants appeared to have been infected in the patient.Implants had to be removed.Swab samples were taken from each component of the prosthesis and the surrounding tissues.The removed prosthesis has been sent for decontamination and will be returned to the office.

• 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: 23520599
• Report Number: 3024706-2025-00011
• Device Sequence Number: 13178386
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• 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 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): 10/09/2025

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
• 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: 09/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 65 YR
• Patient Sex: Female