MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

Catalog Number 320-10-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: liner, 42mm, +2.5mm (cn: 320-42-03; sn: (b)(4)); torque defining screw (cn: 320-20-00; sn: (b)(4)); glenosphere locking screw (cn: 320-15-05; sn: (b)(4)); glenosphere, 42mm (cn: 320-01-42; sn: (b)(4)).

Event Description

The patient was revised due to dislocating.

Manufacturer Narrative

Section h10: (d4) expiration date: 24-feb-2029.(e3) occupation: physician.(g5) pma/510(k)number: k063569.(h3) the revision reported was likely the result of a dislocation.A review of the dhr and/or the sterilization records was not conducted because the event as described does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.The ifu for equinoxe (700-096-060 rev m) was reviewed.Device specific risks include, but are not limited to 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.No information provided in the following section(s): a4, a5, b6, b7, d6, g8.Section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been (b)(6)2019.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8658819
• MDR Text Key: 146667462
• Report Number: 1038671-2019-00309
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/08/2019
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR