MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-10-00

Device Problem Defective Device (2588)

Patient Problem Implant Pain (4561)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: serial number, item number, and full description: (b)(6), 300-01-14 - equinoxe humeral stem primary press fit 14mm, (b)(6), 320-08-38 - glenosphere exp 38mm +4mm offset, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-38-00 - 145-deg pe 38mm hum liner +0.

Event Description

It was reported via clinical study, that approximately 3 years postop the initial implant, this 59 year old male patient was revised due to instability events of his left total shoulder arthroplasty that has been worsening over the last 6 months.He states that his shoulder will dislocate with overhead motions, twisting motions, and sometimes even at rest.When this happens, his pain is a 10/10.The patient¿s outcome was last known as resolved.Devices will not be returned.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17595836
• MDR Text Key: 321648575
• Report Number: 1038671-2023-02005
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Race: White