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

Model Number	NTO156
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information and surgeon assessment, the revision procedure was necessitated by a traumatic event.Intraoperative findings confirmed that the implant had dislocated volarly as a result of the trauma.Given these findings, there is no evidence of device malfunction, design failure, or material defect.The root cause of the event is attributed to the patient's traumatic fall and is unrelated to the device itself.
Event or Problem Description
It was reported that the patient underwent a total joint arthroplasty on (b)(6) 2026.Subsequently, the patient underwent for a revision surgery on (b)(6) 2026, due to a traumatic injury, a hard fall 1 week post initial surgery.During the revision surgery, it was noted that the implant dislocated volarly.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 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: 24716987
• Report Number: 3024706750-2026-00024
• Device Sequence Number: 17649207
• Product Code: SFA
• UDI-Device Identifier: 07640181160044
• UDI-Public: 07640181160044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: NTO156
• Device Catalogue Number: NTO156
• Device Lot Number: 9236
• 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: 03/12/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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 Age: 68 YR
• Patient Sex: Male