MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)

Catalog Number	310-01-44
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices (2): equinoxe square torque define screw drive kit (cn: 300-20-02; sn: (b)(4)).Equinoxe replicator plate 1.5mm o/s (cn: 300-10-15; sn: (b)(4)).
Event or Problem Description
Primary surgery: (b)(6) 2018.Revision due to osteoarthritic changes of the shoulder.Patient has significant deformity.
Additional Manufacturer Narrative
Section h10: (d4) expiration date: 12-jun-2028 (e3) occupation: physician (g5) pma/510(k)number: k042021.(h3) it was reported that a 77 y/o patient received anatomic shoulder replacement on (b)(6) 2018.This shoulder was revised to a reverse shoulder on (b)(6) 2019 due to osteoarthritic changes of the shoulder.The patient has a history of a significant deformity.The patient left the or in stable condition.The device is not returning.No further information is available.Device was used for treatment, not diagnosis.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient conditions.(h4) 14-jun-2018.Section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 14-may-2019.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8662695
• Report Number: 1038671-2019-00319
• Device Sequence Number: 263421
• Product Code: KWT
• UDI-Device Identifier: 10885862083876
• UDI-Public: 10885862083876
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 310-01-44
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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: Required Intervention