MAUDE Adverse Event Report: KERI MEDICAL SA KERIFLEX MCP AND PIP FINGER JOINT PROSTHESES; KERIFLEX - MCP FINGER JOINT IMPLANT - MCP 10

Model Number	210-P10010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.After a thorough investigation (dhr review, complaint history review, medical imaging and reports), the second implant breakage is considered likely linked to the persistence of unfavorable biomechanical conditions identified following the initial implantation.Available information suggests that these conditions may not have been fully corrected during the revision procedure.Consequently, similar mechanical stresses may have persisted, contributing to the recurrence of implant breakage 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
It was reported that following a keriflex revision surgery, the patient is experiencing ongoing pain and functional impairment.A bone scintigraphy and pet scan performed in (b)(6) 2025 revealed mechanical failure (dislocation and fracture), with imaging findings consistent with an active infection and associated lymph node involvement.The surgeon opted out of revision surgery and referred the patient to pain management.

• Brand Name: KERIFLEX MCP AND PIP FINGER JOINT PROSTHESES
• Common Device Name: KERIFLEX - MCP FINGER JOINT IMPLANT - MCP 10
• 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: 25134963
• Report Number: 3024706750-2026-00036
• Device Sequence Number: 9516529
• Product Code: KYJ
• UDI-Device Identifier: 07640181160594
• UDI-Public: 07640181160594
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 210-P10010
• Device Catalogue Number: 210-P10010
• Device Lot Number: 060282002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Female