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

Catalog Number 320-01-38

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

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

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision of equinoxe components.

Manufacturer Narrative

Pending evaluation.Updated with catalog number and device description.

Event Description

Index surgery: (b)(6) 2014.Revision due to liner disengaging from tray.

Manufacturer Narrative

Upon review of all available information, the reported revision was likely the result of either incomplete seating of the humeral liner during implantation, forceful contact between the liner and the glenoid bone (scapular notching), or complete wear of the liner detaching from the humeral adapter tray.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.This device was used for treatment, not diagnosis.Postoperative component loosening is a known complication associated with total shoulder arthroplasty.Per complications of total shoulder arthroplasty (1), postoperative component loosening was the number one most frequent complication of total shoulder arthroplasty, with a prevalence of 39% and 6.3% of all shoulders.There are anywhere from 5% to 42% revision rates (unrestrained and restrained implants).Loosening of the humeral and glenoid components is a common event, accounting for 39% of complications.Factors that have been associated with glenoid stability have included the preservation of the subchondral plate, concentric reaming of the glenoid, biomaterial design and selection, and glenohumeral mismatch of the prosthetic.This device is used for treatment not diagnosis.No information, asked not provided.(1) bohashi, k.I., et al.Complications of total shoulder arthroscopy.Journal of bone and joint surgery, 88:2279-2292, october 2006.

Event Description

It was reported that a patient who was initially had a total shoulder arthroplasty in (b)(6) 2014, experienced a revision due to the liner disengaging from the tray.Reportedly, the patient's health was stable post-op and there were no known concerns postoperatively.This is one of eleven products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00012, 1038671-2018-00013, 1038671-2018-00014, 1038671-2018-00015, 1038671-2018-00016, 1038671-2018-00017, 1038671-2018-00018, 1038671-2018-00019, 1038671-2018-00020 and 1038671-2018-00021.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: EQUINOXE REVERSE GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7147843
• MDR Text Key: 95823612
• Report Number: 1038671-2017-00937
• 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,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention