MAUDE Adverse Event Report: KERI MEDICAL SA Touch - CMC1 Prosthesis; TOUCH® - CMC1 Prosthesis Offset Neck 15° - 8mm - M

Model Number	NTO158
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total joint arthroplasty of touch cmc1 prosthesis.Subsequently, the patient underwent revision surgery, due to pain.Intraoperatively, there was evidence of significant metallosis and pe liner breakage.
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.Based on the available information, the incident is not attributed to a manufacturing or design defect of the specific returned device.Retrieval analysis confirmed a fracture of the liner component, with a crack propagation that extends almost the entire liner.Review of the available medical imaging identified a cup angulated, which confirms the surgeon's statement.After a thorough investigation (returned device, dhr review, complaint history review), it appears that the fracture is most likely due to the cup angulation leading to intraprosthetic conflict as per the surgeon statement.

• Brand Name: Touch - CMC1 Prosthesis
• Common Device Name: TOUCH® - CMC1 Prosthesis Offset Neck 15° - 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: 50178483
• Report Number: 3024706750-2026-00084
• Device Sequence Number: 16098209
• Product Code: SFA
• UDI-Device Identifier: 07640181160051
• UDI-Public: 07640181160051
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: NTO158
• Device Catalogue Number: NTO158
• Device Lot Number: X7425
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: 45 YR
• Patient Sex: Male