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

Model Number 320-10-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

A (b)(6) y/o male patient had a dislocation when son fell on shoulder.The left hrp was originally done a year ago.When the surgeon opened the patient, he noticed the liner was no longer attached to the liner tray.The patient had a successful tray, liner and glenosphere rev hrp/rtsa.Devices will not return.

Manufacturer Narrative

(h3) the revision reported was likely the result of a post traumatic event involving the patient¿s son falling on his affected shoulder, which led to dislocation and humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.

• Brand Name: EQUINOXE
• Type of Device: REVERSE TRAY ADAPTER PLATE TRAY +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10679077
• MDR Text Key: 214798569
• Report Number: 1038671-2020-00577
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR