MAUDE Adverse Event Report: KERI MEDICAL SA Touch - CMC1 Prosthesis; TOUCH® - CMC1 Prosthesis Spherical Cup Ø9 mm / Straight Neck 0° - 6mm - S

Model Number	CTO09 / NTO06
Medical Device Problem Codes	Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	07/13/2026
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 and loosening of the cup.During revision surgery, metallosis was observed, and the stem was found deeper than at primary placement.The cup and neck were revised, and bone resection was performed.
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.

• Brand Name: Touch - CMC1 Prosthesis
• Common Device Name: TOUCH® - CMC1 Prosthesis Spherical Cup Ø9 mm / Straight Neck 0° - 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 reider; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 50869257
• Report Number: 3024706750-2026-00103
• Device Sequence Number: 10674010
• Product Code: SFA
• UDI-Device Identifier: 07640181160075
• UDI-Public: 07640181160075
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/22/2026

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: CTO09 / NTO06
• Device Catalogue Number: CTO09 / NTO06
• Device Lot Number: 9132 / 9132
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: 69 YR
• Patient Sex: Male