MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER

Catalog Number 320-46-00

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Pending revision due to instability.This event report was received through clinical data collection activities.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of instability of the left shoulder joint devices is most likely related to the patient's underlying conditions to include previous significant shoulder maladies.This device is used for treatment, not diagnosis.

Event Description

It was reported through clinical data collection activities that a patient experienced device instability to the left shoulder with an onset of (b)(6) 2018 that required revision surgery on (b)(6) 2018.The revision marked the event as being as "resolved".The patient had described a history of at least 3-5 anterior instability, as subluxations that were self-reduced.The patient has significant medical history for left shoulder surgeries and/or injuries.There is no indication that the device malfunctioned.No additional information is provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2019-05000, 1038671-2019-05001, 1038671-2019-05002 and 1038671-2019-05003.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: EQUINOXE REVERSE HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7544358
• MDR Text Key: 109250745
• Report Number: 1038671-2018-00471
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 95