MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID M, POST AUG, LEFT

Model Number	314-13-23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): 310-61-50, 6468055 - stemless humeral head short, 50mm (beta).Stemless core.300-30-10: equinoxe preserve stem 10mm.310-00-50: equinoxe, humeral head, extra short, 50mm.300-50-45: 4.5mm short rep plate.
Event or Problem Description
As reported, disassociation of polyethylene.Exact date unk: left tsa glenoid shear failure on (b)(6) 2021 xr: the (b)(6) y/o male patient doesn't recall any specific moi and was in pain.The case report form indicates this event is possibly related to devices or procedure.This event report was received through clinical data collection activities.Hospital policy will not allow return of explants.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of fracture of the cage glenoid center cage, which led to pain.The cause of the fracture cannot be determined from the picture and information provided.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, approximately one year postop the initial ltsa for this 70 y/o male, the glenoid plastic sheared off the center peg and was causing the patient a lot of pain and was revised to a reverse with a short stem.It was reported there was no trauma.Patient was last known to be in stable condition following the event.Device will not return due to facility policy.
Event or Problem Description
As reported, approximately one year postop the initial ltsa for this 70 y/o male, the glenoid plastic sheared off the center peg and was causing the patient a lot of pain and was revised to a reverse with a short stem.It was reported there was no trauma.Patient was last known to be in stable condition following the event.Device will not return due to facility policy.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID M, POST AUG, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12067150
• Report Number: 1038671-2021-00311
• Device Sequence Number: 4000175
• Product Code: KWT
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 11/04/2024
• Device Model Number: 314-13-23
• Device Catalogue Number: 314-13-23
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 123