MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5

Model Number 320-42-13

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / sn# (b)(4)); equinoxe reverse 42mm glenosphere (cat# 320-01-42 / sn# (b)(4)); equinoxe reverse torque defining screw kit (cat# 320-20-00 / sn# (b)(4)).

Event Description

As reported, approximately sixteen months post implant, the humeral constrained liner disassociated from the humeral adaptor tray.

Event Description

As reported, approximately thirteen months post implant, the humeral constrained liner disassociated from the humeral adaptor tray.There was no trauma reported.The rep was present at the time of the surgery.The device will be returned for evaluation.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(e3) occupation: physician.(g5) pma/510(k)number: k063569.(h3) the original serial numbers provided by the sales representative do not match the devices returned for evaluation.It is possible that the patient had both shoulders replaced in 2018 and the numbers provided were for the other shoulder, which has not been revised.The serial numbers that match the returned devices were found using exactech sales data, indicating that the index surgery took place on (b)(6) 2018.The revision reported was likely the result of not fully seating the humeral liner at the time of implantation, which allowed for the humeral liner to disassociate from the humeral tray.(h4) device manufacture date: 03-oct-2017.(h6) evaluation codes: 1924, 2923.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, approximately thirteen months post implant, the humeral constrained liner disassociated from the humeral adaptor tray.There was no trauma reported.The rep was present at the time of the surgery.The device will be returned for evaluation.(d4) serial number: (b)(6), expiration date: 01-oct-2022 (d11) concomitant device(s): 320-10-00, 5411487, equinoxe reverse tray adapter plate tray +0.320-01-42, 5493867, equinoxe reverse 42mm glenosphere.320-15-05, 5477384, eq rev locking screw.320-20-00, 5457203, eq reverse torque defining screw kit.(h1) type of reportable event: serious injury.No information provided in the following section(s): a2, a3, a4, a5, b6, b7, g8, h7, h9.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8940141
• MDR Text Key: 189074083
• Report Number: 1038671-2019-00427
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 320-42-13
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention