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

Model Number 320-01-38

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices (2): eq rev locking screw (cn: 320-15-05; sn: (b)(4)).Equinoxe reverse 38mm humeral liner +0 (cn: 320-38-00; sn: (b)(4)).

Event Description

Primary surgery: (b)(6) 2018.The glenosphere was found uncoupled on the x-ray at a 6 month follow up with the patient.Patient was asymptomatic, no pain and with full functioning.

Manufacturer Narrative

(b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d6) if implanted, give date: (b)(6) 2018.(e3) occupation: physician.(g5) pma/510(k)number: k063569.(h4) device manufacture date: 03-oct-2018.(h3) the revision reported was likely the result of not properly aligning the glenosphere relative to the glenoid baseplate during the initial surgery.This misalignment likely prohibited the glenosphere from fully seating and the glenosphere locking screw from fully engaging the glenoid baseplate, resulting in disassociation of the glenosphere.However, this cannot be confirmed as the explants were not available for evaluation.(h6) evaluation codes: 3165, 2907.Section h11: the following sections have corrected information: (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 22-may-2019 (h5) labeled for single use?: yes.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 38MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8663070
• MDR Text Key: 146816149
• Report Number: 1038671-2019-00322
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/22/2019
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention