MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 10MM - L

Model Number	NTO1510
Medical Device Problem Codes	Break (1069); Fracture (1260); Peeled/Delaminated (1454); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Loss of Range of Motion (2032); Joint Impingement (4834)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation related to this event is ongoing.At this time, the available information is insufficient to determine a definitive root cause or whether the device contributed to the reported event.A supplemental mdr will be submitted to fda upon completion of the investigation and when additional information becomes available.
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2024.Subsequently, on (b)(6) 2024 the patient mentioned experiencing a snagging sensation with the prosthesis; therefore, on (b)(6) 2025, a revision surgery was performed due to a fracture of the polyethylene head component.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b6, d4, d9, h3, h4, h6, h11.The reported event could be confirmed since the affected device was returned for investigation.Based on a comprehensive investigation (explant analysis, device history record review, complaint database review, clinical signs), the most probable root cause is mechanical overstress due to neck size too long which explain the pain appearing at 3 months post-op or suboptimal bone preparation leading to bone impingement.Additionally, patient related factors such as heavy activity and external circumstances, such as potential trauma or bone regrowth leading to bone impingement could also contribute to the reported incident.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° - 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: 24662670
• Report Number: 3024706750-2026-00018
• Device Sequence Number: 15759711
• Product Code: SFA
• UDI-Device Identifier: 07640181160068
• UDI-Public: 07640181160068
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NTO1510
• Device Catalogue Number: NTO1510
• Device Lot Number: X6717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Male