MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE, 36MM

Catalog Number	320-31-36
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): humeral stem or stemless (cat# 300-30-06), reverse humeral liner (cat# 320-36-00), reverse humeral tray (cat# 320-10-00), reverse glenosphere baseplate (cat# 320-35-03).
Event or Problem Description
As reported, the (b)(6) female patient has a history of rotator cuff repair, primary glenohumeral arthrosis, hypertension, and hyperthyroidism.This patient¿s initial left tsa of the was on (b)(6) 2019.The patient was revised on (b)(6) 2019 due to septic loosening.The devices will not be returned.The study database indicates the event is resolved.All available information has been received at this time.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 16-jul-2029.(h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is unknown at this time however is most likely patient conditions.(h4) device manufacture date: 18-jul-2019.

• Brand Name: EQUINOXE
• Common Device Name: GLENOSPHERE, 36MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9595892
• Report Number: 1038671-2020-00005
• Device Sequence Number: 2525681
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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 Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: 72 YR
• Patient Weight: 81