MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 8MM - M

Model Number	TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 8MM - M
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561); Joint Impingement (4834)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigations.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 (medical imaging, returned device, device history record review, complaint history review), it appears that the premature breakage of the pe liner is most probably due to the patient activity (stone sculpting) involving repeated medium- to high-intensity impacts.In addition to this, the surgeon assessment (neck too long) indicates an increased risk of mechanical overstress, and the explant analysis revealed signs of initial intra-prosthetic conflict.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 72-year-old male patient underwent a primary touch implantation on (b)(6) 2022 on the left thumb and a revision on (b)(6) 2025.He has been experiencing thumb pain since (b)(6) 2025.He works as an artisan and he participated in a stone-sculpting course, which involved significant mechanical stress on the hand.During the revision, the pe liner was found fractured at the pole.On closer inspection, it was noted that the edge of the pe was thinner at the pole than on the side, which indicates, as per the surgeon, that the initial neck length was too long.Metallosis was also observed, tissues were sent for lab testing.Since the cup was still in good condition and showed no scratches, the surgeon only replaced the neck.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 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: 23875573
• Report Number: 3024706750-2025-00037
• Device Sequence Number: 21450053
• Product Code: SFA
• UDI-Device Identifier: 07640181160051
• UDI-Public: 07640181160051
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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 OFFSET NECK 15° - 8MM - M
• Device Catalogue Number: NTO158
• Device Lot Number: X5732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: Male