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

Model Number	314-13-22
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-62-02 - stemless humeral comp integrip, cage, size 2; 310-61-44 - stemless humeral head 44mm x 17mm x alpha.
Event or Problem Description
As reported, approximately 3 years post op the initial left tsa, this (b)(6) female patient's was revised due to aseptic glenoid loosening.Patient had a subscap failure and a loose tsa glenoid in stemless implant.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 24-jun-2023 (h3) the revision reported was likely the result of both patient-related conditions and an insufficient bond between the cage glenoid and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the device was not available for evaluation and pre-revision x-rays were not provided.(h4) device manufacture date: 26-jun-2018.Section h11: *the following sections have corrected information: (d10) concomitant device(s): 300-62-02, 5483855 - stemless humeral comp integrip, cage, size 2, 310-61-44, 5351181 - stemless humeral head 44mm x 17mm x alpha.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID S, POST AUG, LEFT
• 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: 13341919
• Report Number: 1038671-2022-00041
• Device Sequence Number: 3828990
• Product Code: KWT
• UDI-Device Identifier: 10885862196163
• UDI-Public: 10885862196163
• 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: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 06/24/2023
• Device Model Number: 314-13-22
• Device Catalogue Number: 314-13-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White