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

Catalog Number	314-13-34
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: equinoxe preserve stem 12mm (cn# 300-30-12); equinoxe, humeral head expanded, 50mm (beta) (cn# 310-03-50); equinoxe replicator plate 4.5mm o/s (cn# 300-10-45).
Event or Problem Description
It was reported that a male patient received a right shoulder arthroplasty on (b)(6) 2019.Patient was then revised due to instability/subluxation.
Additional Manufacturer Narrative
Section h10: (g5) pma/510(k)number: k113309.(h3) 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, instability/subluxation, is related to the underlying patient conditions.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID L, POST AUG, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9034124
• Report Number: 1038671-2019-00449
• Device Sequence Number: 19600339
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 314-13-34
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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 Weight: 68