MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 10MM - L

Model Number	TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 10MM - L
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	09/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, since the affected device was returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities related to the reported event.After a thorough investigation (returned device, dhr review, complaint history review), it appears that a combination of slight angulation of components (stem too palmar + cup too ulnar + moderately lateralised neck) led to dislocations.The breakage of the pe liner is most likely caused by misaligned stresses occuring during the clamping movement.The most probable root cause of this event is a surgical technique error.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.
Event or Problem Description
The patient experienced multiple dislocations following the initial implantation on (b)(6) 2022, requiring several closed and open reductions between (b)(6) 2022 and (b)(6) 2025, with progressive adjustments from a medium to a long neck offset and finally to a long neck 0° configuration, along with periods of immobilization using a cast and rizoloc brace.The revision surgery revealed metallosis and contact between neck and cup with possible dislocation.Replacement by neck nto010.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 10MM - L
• 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: 23520552
• Report Number: 3024706750-2025-00008
• Device Sequence Number: 13165091
• Product Code: SFA
• UDI-Device Identifier: 07640181160068
• UDI-Public: 07640181160068
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/07/2025

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 Expiration Date: 12/01/2024
• Device Model Number: TOUCH® - CMC1 PROSTHESIS OFFSET NECK 15° - 10MM - L
• Device Catalogue Number: NTO1510
• Device Lot Number: 4114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2019
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG