MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM / STRAIGHT NECK 0° - 10MM - L

Model Number	CTO109 / NTO010
Medical Device Problem Codes	Break (1069); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a joint arthroplasty of touch cmc1 prosthesis revision on (b)(6) 2025.Subsequently, the patient underwent a second revision due to breakage of the polyethylene (pe) liner.The surgeon revised the neck and the cup.
Additional Manufacturer Narrative
The reported event was confirmed as the affected device was returned for investigation.A review of the device history record for the reported lot revealed no anomalies related to the event.Based on a comprehensive investigation (including evaluation of the returned device, review of the device history record, and assessment of the complaint history), the event appears to be primarily associated with an initial intra-prosthetic conflict due to slight cup angulation which led to bone impingement.These factors, potentially exacerbated by patient-specific conditions such as metabolic oxidation or joint hyperlaxity, may have contributed to the observed failure.Furthermore, this is the second case of revision of the type for this patient with associated complaint.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM / STRAIGHT NECK 0° - 10MM - L
• 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: 24597892
• Report Number: 3024706750-2026-00014
• Device Sequence Number: 20974587
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: CTO109 / NTO010
• Device Catalogue Number: CTO109 / NTO010
• Device Lot Number: 8838 / X7243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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