MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. NEUFLEX; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number 1234-40-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Pain (1994); Swelling (2091)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

Mcp implant placed during right index mp silastic arthroplasty.Patient experienced symptom relief a couple of months after.Later in the year, xrays reviewed - arthroplasty well incorporated.Significant arthritis w/ deviation noted at pip joint.Patient seen with doctor, who reviewed treatment options including pip joint fusion vs working with hand ot to see how much mobility can be recovered.Doctor warned that patient may develop increased pain at her pip joint while working on rom but patient is interested in proceeding.Plan for return to clinic in 2 months.Patient returned with increased pain and swelling.Fluoroscopic imaging obtained today shows the implant appears well seated in the proximal phalanx and metacarpal with no evidence of osteolysis.However it looks as though the implant may be broken at the hinge.

• Brand Name: NEUFLEX
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46581
• MDR Report Key: 7036849
• MDR Text Key: 92216070
• Report Number: 7036849
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1234-40-000
• Device Catalogue Number: 123440000
• Device Lot Number: 723814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2017
• Date Report to Manufacturer: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 16