MAUDE Adverse Event Report: KERI MEDICAL SA KERIFLEX MCP AND PIP FINGER JOINT PROSTHESES; KERIFLEX - MCP FINGER JOINT IMPLANT - PIP 2

Model Number	210-P20002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	03/20/2026
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 (returned device, dhr review, complaint history review), it appears that the fracture is most likely due to a surgical technique error resulting in the implant being excessively constrained.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 a patient underwent a joint arthroplasty on march 2025; subsequently on (b)(6) 2026, the patient reported pain and a clicking sensation when moving the finger, along with swelling and slight deviation.The patient underwent a revision surgery following breakage of the keriflex pip 2 implant.It was reported that the implant fractured at the hinge point.During the revision procedure, the implant was removed and replaced with a new keriflex pip 2 implant.

• Brand Name: KERIFLEX MCP AND PIP FINGER JOINT PROSTHESES
• Common Device Name: KERIFLEX - MCP FINGER JOINT IMPLANT - PIP 2
• 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: 25182894
• Report Number: 3024706750-2026-00038
• Device Sequence Number: 10333662
• Product Code: KYJ
• UDI-Device Identifier: 07640181160662
• UDI-Public: 07640181160662
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K211385
• 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): 05/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 210-P20002
• Device Catalogue Number: 210-P20002
• Device Lot Number: 060282009000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female