MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID EXTRA LARGE, BETA

Model Number	314-13-15
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The glenoid loosening reported was likely the result of an insufficient bond between the implant and the bone, patient-related conditions, or a combination of the two.However, this cannot be confirmed as the devices were not returned for evaluation.Concomitant device(s): 300-01-15, equinoxe, humeral stem primary, press fit 15mm.310-01-50, equinoxe, humeral head short, 50mm (beta).300-10-45, equinoxe replicator plate 4.5mm o/s.
Event or Problem Description
As reported, approximately 5 years postop the initial implant, this (b)(6) y/o male presented with right aseptic glenoid loosening and was revised.The case report form indicates this event is not related to devices and definitely related to the procedure.The patient was discharged in 2 days.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (b3) date of event: 03-mar-2021.(d6b) if explanted, give date: (b)(6) 2021.(h6) health effect - impact code: 4629, device revision or replacement; component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID EXTRA LARGE, BETA
• 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: 11250293
• Report Number: 1038671-2021-00021
• Device Sequence Number: 3562860
• Product Code: KWT
• UDI-Device Identifier: 10885862172723
• UDI-Public: 10885862172723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 314-13-15
• Device Catalogue Number: 314-13-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White