MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM GLENOSPHERE

Model Number	320-01-46
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): 308-10-05, (b)(4) - large prox body +0; 308-10-25, (b)(4) - 25mm middle segment modular; 308-15-25, (b)(4) - taper locking screw 25; 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 320-15-05, (b)(4) - eq rev locking screw; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-46-13, (b)(4) - equinoxe reverse 46mm humeral const liner +2.5.
Event or Problem Description
As reported, approximately 5 weeks postop a right tsa, a (b)(6) y/o male patient¿s shoulder was revised due to dislocation.The surgeon changed out the proximal body, hrp taper locking screw, humeral adapter tray, reverse shoulder fixed angle torque defining screw and the reverse shoulder humeral liner.Patient was last known to be in stable condition following the event.Devices not returning, the patient requested them.
Additional Manufacturer Narrative
Section h10: (h3) upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result pain, infection, dislocation, or loosening of total joint hardware.The most likely cause of the reported event is the size of the original implanted devices.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10363446
• Report Number: 1038671-2020-00369
• Device Sequence Number: 11514418
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• 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 Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 320-01-46
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 97