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

Model Number	NTO1510 / UNKNOWN
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Aseptic loosening (4883)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty of touch cmc1 prosthesis on 2023 and a revision surgery on 2024.Subsequently, the patient underwent a third revision surgery on (b)(6) 2026 due to prosthetic dislocation.During the revision, the neck was removed and the cup was found to be loose, and the dorsal cap of the trapezium was fractured.Signs of mild metallosis were also observed.Due to insufficient space to implant a new neck, the stem was removed, and a proximal metacarpal resection was performed.A new stem was then implanted.
Additional Manufacturer Narrative
Based on the information available, a definitive root cause could not be determined.The explanted device and associated clinical documentation were not provided to the manufacturer, which significantly limits the scope and conclusiveness of the investigation.Review of the available radiographic images suggests insufficient trapezial bone stock, which may have affected cup fixation and implant positioning.As outlined in the device instructions for use (ifu), implantation of the touch device is contraindicated in cases of poor bone quality that may preclude adequate fixation, as well as in cases where patient bone dimensions are incompatible with the available implant sizes.Nevertheless, this potential contributing factor cannot be confirmed in the absence of device retrieval and further analysis.Should additional information becomes available, the investigation will be revised accordingly and a follow-up report will be submitted.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 10MM - L / UNKNOWN CUP
• 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: 24714984
• Report Number: 3024706750-2026-00022
• Device Sequence Number: 6013208
• Product Code: SFA
• UDI-Device Identifier: 07640181160068
• UDI-Public: 07640181160068
• 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 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): 03/25/2026

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 / UNKNOWN
• Device Catalogue Number: NTO1510 / UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74 YR
• Patient Sex: Male