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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561); Joint Impingement (4834)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the incident is not attributed to a manufacturing or design defect of the specific returned device.Mechanical complication and dislocation are known adverse events listed in the device's instruction for use (ifu) and subject to trend reporting.In addition, the explant exhibited signs of initial intra-prosthetic impingement; however, the underlying cause of this impingement could not be determined with certainty.
Event or Problem Description
It was reported that a patient underwent a total joint arthroplasty of touch cmc1 prosthesis.Subsequently, the patient presented pain and a dislocated prosthesis, a reduction was performed under fluoroscopy, and malalignment of the neck head was noted therefore, the patient underwent a revision.
Additional Manufacturer Narrative
This mdr is being retracted due to misidentification of manufacturing report.A new mdr with the correct manufacturing report has been submitted.

• 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: 25651473
• Report Number: 3024706750-2026-00828
• Device Sequence Number: 5902900
• Product Code: SFA
• UDI-Device Identifier: 07640181160051
• UDI-Public: 07640181160051
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: NTO158
• Device Catalogue Number: NTO158
• Device Lot Number: X5593
• Date Returned to Manufacturer: 06/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: 74 YR
• Patient Sex: Male