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

Model Number 314-13-22

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 11/16/2021

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 281739393
• Report Number: 1038671-2021-00660
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862196163
• UDI-Public: 10885862196163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female