MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM / OFFSET NECK 15° - 6MM - S

Model Number	CTO109/NTO156
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Implant Pain (4561)
Date of Event	02/09/2026
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 (returned device, device history review record, medical imaging, complaint history review and surgeon assessment), the most probable root cause is linked to patient related factors (ossification), rather than a device problem.Ossification is listed as a probable adverse effect in the device ifu, and therefore is an anticipated potential outcome.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
The surgeon reported that a 70-year-old patient underwent revision surgery 28 months after the initial operation due to pain on exertion, described as similar to the symptoms experienced prior to implantation of the prosthesis.This surgical procedure was performed on (b)(6) 2026, consisting of release of the peri-prosthetic tissues and maximal removal of the ossification.It was not possible to advance the stem any further.The cup was therefore removed and reimplanted deeper and the neck was replaced.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM / 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: 24760627
• Report Number: 3024706750-2026-00009
• Device Sequence Number: 18722388
• Product Code: SFA
• UDI-Device Identifier: 07640181160099
• UDI-Public: 07640181160099
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: CTO109/NTO156
• Device Catalogue Number: CTO109/NTO156
• Device Lot Number: 6998/X6744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 04/01/2026
• 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: 70 YR
• Patient Sex: Male