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

Catalog Number	314-13-24
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): post aug cemented left (cat# 314-13-24 / sn# (b)(4)).Torque defining square drive (cat# 300-20-02 / sn# (b)(4)).Replicator plate 4.5mm offset (cat# 300-10-45 / sn# (b)(4)).
Event or Problem Description
As reported, approximately 2 years post-op the initial tsa for this (b)(6) female, the initial reason for revision was thought to be cuff failure but once we opened the patient up it was apparent the glenoid was loose.There has been catastrophic posterior wear of the component which has created an osteolytic response and then loosened the implant.Patient was last known to be in stable condition following the event.The devices will not be returned per hospital policy.All available information has been received at this time.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of either instability, the humeral head not articulating in the center of the glenoid components¿ articulation surface, an insufficient rotator cuff, or a combination of the three which led to significant posterior/inferior wear of the articulating surface.The significant wear likely resulted in an osteolytic response and subsequent aseptic (non-infected) glenoid loosening.Section h11: the following sections have corrected information: (d11) concomitant device(s): equinoxe humeral head, short, 50mm (cat# 310-01-50 / sn# (b)(6)) torque defining square drive (cat# 300-20-02 / sn# (b)(6)) replicator plate 4.5mm offset (cat# 300-10-45 / sn# (b)(6)) (g3) report source: should of been checked "health professional" on initial submission.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID L, POST AUG, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9617875
• Report Number: 1038671-2020-00012
• Device Sequence Number: 19513376
• Product Code: KWT
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 04/16/2023
• Device Catalogue Number: 314-13-24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR