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

Model Number 320-10-00

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

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

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation.Dislocation shown on x-ray.The tray and poly were sitting outside the glenosphere and the poly wasn¿t fully seated.

Event Description

As reported, the patient had a revision on (b)(6) 2019 due to dislocation.The x-rays showed that the tray and poly were sitting outside of the glenosphere and that the poly wasn't fully seated.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(e3) occupation: physician.(h3) the revision reported may have been the result of not fully assembling the humeral liner to the adapter tray at the time of the original surgery, which led to disassociation of the humeral liner from the adapter tray and subsequent dislocation.However, this cannot be confirmed because the backside of the humeral liner is too damaged to determine if the locking button completely assembled to the mating feature of the tray during the original surgery.(h6) evaluation codes: 1924, 2923.Section h11: *the following sections have corrected information: (b5) as reported, the patient had a revision on (b)(6) 2019 due to dislocation.The x-rays showed that the tray and poly were sitting outside of the glenosphere and that the poly wasn't fully seated.(g3) report source: should of been health professional on initial report.No information provided in the following section(s): a2, a3, a4, a5, b6, d6, d11, g8, h4, h7, h9.

• 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: 8514939
• MDR Text Key: 141954545
• Report Number: 1038671-2019-00242
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-10-00
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Hospitalization; Required Intervention