MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOSPHERE

Catalog Number 320-01-38

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2014.Revision of shoulder components due to instability and low grade scapular notching.

Manufacturer Narrative

After further review of additional information received the following sections b4, b5, b6, b7, d4 expiration date, g4, g5, g7, h2, h4 and h6 have been updated accordingly.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.Device specific risks that fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.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 patient instability of the shoulder joint devices is most likely due to the patient's underlying conditions.This device is used for treatment, not diagnosis.Section(s): information not provided: a2, a4, a5 and a6.Corrected data: no device evaluation pending.

Event Description

It was reported that a patient experienced a revision surgery of shoulder devices due to instability.The patient was not stable and was experiencing signs of low-grade scapular notching.The surgeon revised the following devices: the glenosphere, 38mm +0 liner and +0 adapter tray were removed.The surgeon trialed the following: 42mm glenosphere was trialed with 42mm +0 liner but still felt unstable.The surgeon chose and implanted the following devices: 42mm +2.5 liner, +0 adapter tray and 42mm glenosphere.The surgical outcome was successful for the patient, good range of motion was reported.There is no indication or complaint that the device malfunctioned.No additional information has been provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00399 and 1038671-2017-00400.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6652974
• MDR Text Key: 77924762
• Report Number: 1038671-2017-00398
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention