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	Pain (1994)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): 310-01-44, 3836613, equinoxe, humeral head short, 44mm (alpha).
Event or Problem Description
Approximately 2 years postop the initial left tsa, the (b)(6) y/o female patient complained of pain and weakness.An arthroscopy was completed to investigate and saw that the glenoid poly was loose in the joint.During a revision, the humerus was moved out of the way and the poly came out at the same time.The center peg dislodged off the prothesis and stayed within the glenoid vault.Peripheral pegs still intact.The poly was sent to pathology for further investigations /infection as well as the humeral head.Humeral head prosthesis was replaced, anatomic shoulder was converted to a hemi and after the investigations are complete, it will be converted to a reverse.Patient was last known to be in stable condition following the event.Devices will not return, sent to laboratory after the procedure.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the glenoid component, which may have resulted in subsequent pain and cage disassociation.However, this cannot be confirmed because the component was not returned for evaluation.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID S, POST AUG, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9981409
• Report Number: 1038671-2020-00277
• Device Sequence Number: 4442169
• Product Code: KWT
• UDI-Device Identifier: 10885862196163
• UDI-Public: 10885862196163
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 01/09/2022
• Device Model Number: 314-13-22
• Device Catalogue Number: 314-13-22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR