MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM

Model Number	CTO109
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Aseptic loosening (4883)
Date of Event	12/01/2025
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.The patient remained asymptomatic until (b)(6) 2025, when he experienced a sudden onset of pain while lifting his niece.The patient was re-evaluated in (b)(6) 2026, at which time imaging showed a change in cup alignment without clear signs of instability or osteolysis; the cup was therefore suspected to be loose.Subsequently, the patient underwent a revision surgery on (b)(6), 2026, during the surgery it was assessed that due to insufficient bone stock to achieve stable fixation of a 10 mm cup component, the procedure was converted to a trapeziectomy.
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, medical imaging, dhr review and complaint history review), it remains unclear why the cup tilted 16 months post-implantation.A potential traumatic event while the patient was lifting his niece may have contributed to the event; however, a definitive root cause cannot be determined with certainty.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM
• 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: 24815704
• Report Number: 3024706750-2026-00023
• Device Sequence Number: 6146304
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: CTO109
• Device Catalogue Number: CTO109
• Device Lot Number: 6878
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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: 61 YR
• Patient Sex: Male