MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL LINER +0

Model Number 320-46-00

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 320-02-46.6480696 - 46x21mm glenosphere high moment arm.320-10-00 , 6487055- equinoxe reverse tray adapter plate tray +0.320-15-05 , 6362580 - eq rev locking screw.320-20-00, 6464845 - eq reverse torque defining screw kit.

Event Description

It was reported that this patient had a revision which was not previously reported.Reason has not been reported.This was found during the investigation of (b)(4).(mdr# 1038671-2022-00072).

Manufacturer Narrative

Section h10: (d4) unique identifier (udi) #: (b)(4).(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision cannot be conclusively determined; reason not reported.Section h11: *the following sections have corrected information: (b5) describe event or problem: a revision was identified while investigating another complaint mdr# 1038671-2022-00072, this 84 y/o male had a revision which was not previously reported.Reason has not been provided.No additional information has been provided after multiple attempts.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 46MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14620282
• MDR Text Key: 293458497
• Report Number: 1038671-2022-00633
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 108 KG