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

Model Number	320-46-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00633
• Device Sequence Number: 5367435
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 108 KG