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

Model Number	314-13-22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 310-01-44, 6744741 - eq humeral head short 44mm alpha, 300-51-45, 6141041 - 4.5mm short fa rep plt kit.
Event or Problem Description
As reported, approximately 2 months postop the initial r tsa this (b)(6) y/o female patient had early instability following a anatomic shoulder.She had an anteverted glenoid and an augment was used to correct this originally.Decision was made to convert to a reverse.Upon revision subscap was solid and all components appeared solidly fixed.Stem was retained.Reason for instability is unknown.Patient was last known to be in stable condition following the event.Facility policy doe not allow devices to be returned.
Additional Manufacturer Narrative
(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 instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• 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: 12933364
• Report Number: 1038671-2021-00660
• Device Sequence Number: 14669853
• Product Code: KWT
• UDI-Device Identifier: 10885862196163
• UDI-Public: 10885862196163
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/19/2022

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: 01/25/2026
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female