MAUDE Adverse Event Report: KERI MEDICAL SA KERIFLEX® MCP AND PIP FINGER JOINT PROSTHESES; KERIFLEX PIP 3

Model Number PIP3

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 03/03/2024

Event Type  Injury  

Event Description

A keriflex revision was done due to a broken implant 1 year after surgery.The surgeon reported a small fracture that occurred while reaming the middle phalanx during primary surgery, but no stabilization was needed and the fracture has since healed.The patient is generally healthy and has no bone disease.The surgeon injected the joint with steroids several months before the replacement.He also had to perform tenolysis under local anaesthetic on this finger in (b)(6) 2023 for stiffness.Movement improved, but the pain never improved.Revision surgery took place on monday (b)(6) 2024 with removal of the device and replacement with a larger size.(the event has been recorded by keri medical sa on 03/06/2024 and occured in uk).

Manufacturer Narrative

Up-to-date investigation summary: no device associated with this report nor medical imaging (e.G.Xrays) were received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Review of the device history records did not reveal any related deviations or anomalies.Failure of the implant due to fatigue, wear or over-loading, improper implant size or position, uncorrected or recurrent deformity, or inadequate soft tissue or bony support and/or excessive activity of the affected joint is a documented side effect (ifu).Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: KERIFLEX® MCP AND PIP FINGER JOINT PROSTHESES
• Type of Device: KERIFLEX PIP 3
• Manufacturer (Section D): KERI MEDICAL SA; route des acacias, 45a; geneva, CH-12 27; SZ CH-1227
• Manufacturer (Section G): KERI MEDICAL FRANCE; 34 rue antoine redier; archamps, FR-74 160; FR FR-74160
• Manufacturer Contact: julien oudot ; route des acacias, 45a; geneva, CH-12-27 ; SZ CH-1227
• MDR Report Key: 19041527
• MDR Text Key: 339379533
• Report Number: 3024706750-2024-00001
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 07640181160679
• UDI-Public: 07640181160679
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K211385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/04/2024

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 Operator: Health Professional
• Device Model Number: PIP3
• Device Catalogue Number: 210-P20003
• Device Lot Number: 052916003000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention