MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S

Model Number	TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Joint Impingement (4834)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a second revision (on (b)(6) 2024) due to pe liner fracture.A thorough debridement was carried out due to significant metallosis.The cup was changed and repositioned with a size 9 cup to achieve better centering.The neck was replaced with an nto08.
Additional Manufacturer Narrative
The reported event could be confirmed, since the affected device was returned for investigation.Following investigation, including dhr analysis, explant and x-ray analysis revealed a material creep on the pe liner indicating overstress and a metal overflow on the inner surface of the cup, which blocks the mobility of the pe liner.This cup deformation is most likely the result of mechanical conflict with the neck rather than a device-related defect.The cup should have been replaced during the first revision surgery to prevent recurrence of pe liner failure.The most probable root cause of this event is a surgical technique error.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
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 6MM - S
• 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: 23520969
• Report Number: 3024706750-2025-00018
• Device Sequence Number: 18568153
• Product Code: SFA
• UDI-Device Identifier: 07640181160044
• UDI-Public: 07640181160044
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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° - 6MM - S
• Device Catalogue Number: NTO156
• Device Lot Number: X8868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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 Sex: Male