MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 6MM - S

Model Number	NTO06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Synovitis (2094); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	03/26/2026
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 a second total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2025.Subsequently, the patient underwent a third revision surgery on (b)(6) 2026 due to pain and polyethylene line breakage.The surgeon did a synovectomy, removal of metallosis, replaced the cup and the neck.Additionally, 2-3 mm were resected from the trapezial surface and placed a new cup in a new bone bed deeper.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b6, d9, h3, h6, h11.The reported event could be confirmed since the affected device was returned for investigation.After a thorough investigation (returned device, dhr review, complaint history review and medical imaging), the most probable root cause of this second recurrence of premature pe liner fracture is the persistence of the mechanical factors previously identified after the first revision, namely insufficient bone resection, cup instability, and intra-prosthetic impingement related to the selected neck configuration.These mechanical complications are expected undesirable side-effects listed in the device's ifu.As the cup was not replaced or repositioned during the first revision, the same mechanical conditions may have persisted, leading to recurrence of the same failure mode.A patient-related contributing factor, including a possible local oxidative environment, cannot be excluded.

• Brand Name: TOUCH - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 6MM - S
• 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: 24966090
• Report Number: 3024706750-2026-00030
• Device Sequence Number: 4978832
• Product Code: SFA
• UDI-Device Identifier: 07640181160013
• UDI-Public: 07640181160013
• 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: 2025
• Device Explanted Year: 2026
• 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): 05/15/2026

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: NTO06
• Device Catalogue Number: NTO06
• Device Lot Number: X8295
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Male