MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS SPHERICAL CUP Ø9MM

Model Number	TOUCH® - CMC1 PROSTHESIS SPHERICAL CUP Ø9MM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, since the affected device was returned for investigation.The device inspection revealed the following: a review of the device history for the reported lot did not indicate any abnormalities related to the reported event.A worldwide complaint database search found one other reported incident (s) for this product/lot combination since release for distribution, but the root cause could not be determined because of insufficient information.After a thorough investigation (returned device, device history record review, complaint history review), it appears that an initial intra-prosthetic conflict took place leading to the cup loosening.The most probable root cause of this event is a surgical technique error.
Event or Problem Description
It was reported that the patient underwent revison surgery following intra-prosthetic conflict, loosening, pain and metallosis.He had no trauma.He felt comfortable for the first couple of months and then became progressively painful.Patient expressed pain in hand around may time.Surgeon suspected cup loosening and decided to bring him back for a revision of cup and neck.Upon revision, a lot of metallosis within joint, small fragment of metal were noted, surgeon removed a lot of the black tissue and took specimens as various points.The cup and stem were well integrated into the bone however there was bone loss in both the proximal metacarpal and distal trapezium.The surgeon proceeded by removing all implants and black tissues.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS SPHERICAL CUP Ø9MM
• 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: 23510762
• Report Number: 3024706750-2025-00005
• Device Sequence Number: 18577401
• Product Code: SFA
• UDI-Device Identifier: 07640181160075
• UDI-Public: 07640181160075
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: TOUCH® - CMC1 PROSTHESIS SPHERICAL CUP Ø9MM
• Device Catalogue Number: CTO09
• Device Lot Number: 4510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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 Sex: Male
• Patient Weight: 76 KG