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

Model Number	TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 8MM - M
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Implant Pain (4561); Joint Impingement (4834)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient came in consultation because of pain and discomfort since a few months.He underwent a revision surgery 24 months post operative.Revision revealed no metallosis but the pe liner is visually damaged.Surgeon resected bone and placed a new neck nto08.
Additional Manufacturer Narrative
The reported event could be confirmed, since the affected device was returned for investigation.The most probable root cause of the event is a combination of multiple factors: a malpositioning of the cup (angulation and non-optimal centring) which led to intra prosthetic conflict bone regrowth which led to bone impingement.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 8MM - M
• Manufacturer (Section D): KERI MEDICAL SA; 5 chemin du pre-fleuri; plan-les-ouates, 1228 ; SZ 1228
• Manufacturer (Section G): KERI MEDICAL FRANCE; 34 rue antoine redier; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; 5 chemin du pre-fleuri; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 23520965
• Report Number: 3024706750-2025-00017
• Device Sequence Number: 9704935
• Product Code: SFA
• UDI-Device Identifier: 07640181160020
• UDI-Public: 07640181160020
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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
• Device Model Number: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 8MM - M
• Device Catalogue Number: NTO08
• Device Lot Number: X6465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 75 KG