MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS SPHERICAL CUP Ø9 MM / STRAIGHT NECK 0° - 8MM - M

Model Number	CTO09 / NTO08
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.After a thorough investigation (medical imaging, returned device analysis, dhr review, and complaint history review), the most probable root cause of the lateral breakage of the pe liner by the neck appears to be patient-specific factors (trauma or osteolysis of the trapezium potentially leading to cup tilting), combined with an initial intra-prosthetic conflict resulting in pe liner blockage.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty of touch cmc1 prosthesis on (b)(6) 2022.Subsequently, the patient underwent revision surgery 4 years after the initial implantation due to loosening of the trapezial cup.Intraoperatively, an intra-prosthetic dislocation was identified, along with significant bone loss of the trapezium estimated at 75%.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS SPHERICAL CUP Ø9 MM / STRAIGHT NECK 0° - 8MM - M
• 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: 24927061
• Report Number: 3024706750-2026-00029
• Device Sequence Number: 5180342
• Product Code: SFA
• UDI-Device Identifier: 07640181160075
• UDI-Public: 07640181160075
• 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 Implanted Year: 2022
• 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): 04/16/2026

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: CTO09 / NTO08
• Device Catalogue Number: CTO09 / NTO08
• Device Lot Number: 5477 / 4117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 82 YR
• Patient Sex: Male