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

Model Number	PIP3
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Event or Problem 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).
Additional 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.
Additional Manufacturer Narrative
After a thorough investigation (returned device, xrays, device and complaint history review), it appears that the root cause of this case of failure cannot be dertermined with certainty.However, one significant possibility is that the surgeon might have damaged the implant during the tenolysis procedure performed in (b)(6) 2023.A small scalpel strike during tenolysis could explain the observed fracture.Additionally, the stiffness in the patient's finger suggests that the implant might have been subjected to excessive stress, possibly due to substantial fibrosis.Causes of early failure of the implant are multifactorial including 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.
Event or Problem 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).

• Brand Name: KERIFLEX® MCP AND PIP FINGER JOINT PROSTHESES
• Common Device Name: 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
• Report Number: 3024706750-2024-00001
• Device Sequence Number: 17952586
• Product Code: KYJ
• UDI-Device Identifier: 07640181160679
• UDI-Public: 07640181160679
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K211385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• 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: Unknown