MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE LINER, 38MM

Catalog Number 320-38-13

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

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

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: 2014.Revision due to humeral liner disassociation.

Event Description

It was reported that a patient experienced a reverse total shoulder arthroscopy revision surgery due to humeral liner disassociation.Following the incision and dissection, the surgeon noted that the liner was detached from the humeral adapter tray.The surgeon revised the tray, liner and glenosphere.The patient was stable following the surgery.No additional information on the patient or event has been provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00859, and 1038671-2017-00861.

Manufacturer Narrative

After further review of additional information received the following sections a1, a3, b4, b5, b6, b7, d4 cat #, sn & exp date, d6, g1, g3, g4, g5, g7, h1, h2, h3, h4 and h6 have been updated accordingly.Section h3: the complaint product was not returned for analysis.The condition of humeral liner disassociation was not confirmed.The frequency of occurrence ranking is very low; therefore, this does not appear to be a design issue.The company is not aware of receiving any other complaint reports involving another part from these manufacturing lots of (b)(4) (adapter tray), (b)(4) (liner) and (b)(4) (glenosphere) pieces that have been in the field since 2014.A review of the device history record for the adapter tray and humeral liner showed that the named devices were accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.The revision reported was likely the result of incomplete seating of the liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or extreme wear of the liner, which led to the liner detaching from the humeral adapter tray.However, these cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.There is no patient medical information provided; therefore, it is not possible to assess the patient risk clinical factors.In a review of the labeling and ifu ifu 700-096-060 rev.M, device specific risks include: fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.It is also noted that excessive wear of the implant components secondary to impingement of components or damage of articular surfaces can cause early implant failure.Also, , it is a known complication that a patient's age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.This device is used for treatment not diagnosis.No new information provided about the patient or event, asked not provided.

• Brand Name: EQUINOXE REVERSE LINER, 38MM
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7105605
• MDR Text Key: 95059325
• Report Number: 1038671-2017-00860
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: 320-38-13
• 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
• Patient Age: 70 YR