MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Model Number	320-42-13
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) male patient required a revision about 5 months post op due to dislocation.Patient was last known to be in stable condition following the event.Devices will not be returning.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation concomitant medical device(s): 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 320-15-05, (b)(4) - eq rev locking screw.
Event or Problem Description
As reported, this male patient required a poly change as the patient had torn soft tissue off the shoulder structure.
Additional Manufacturer Narrative
Section h10: (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 the dislocation and subsequent closed reduction cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, this male patient required a poly change as the patient had torn soft tissue off the shoulder structure.
Additional Manufacturer Narrative
Section h10: (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 the sub scapularis tear and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.Section h11: *the following sections have corrected information: (d4) expiration date: please disregard date on first report (d6a) if implanted: (b)(6) 2016.(d6b) if explanted: (b)(6) 2017.(d10) concomitant device(s): (b)(6) torque defining screw kit, (b)(6) glenosphere locking screw, (b)(6) constrained humeral liner, 42mm, +2.5, (b)(6) humeral adapter tray, +0.(g4) pma/510(k)number: k110708.(h4) device manufacture date: please disregard date on first report.

• Brand Name: EQUINOXE
• Common Device Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• 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: 13333699
• Report Number: 1038671-2022-00038
• Device Sequence Number: 11161653
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2022

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: 03/15/2020
• Device Model Number: 320-42-13
• Device Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 05/26/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male