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

Catalog Number	320-01-36
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: 300-01-09, 5146512, stem 9mm; 320-20-30, 4980346, compression screw, 4.5 x 30mm; 320-20-30, 4935445, compression screw, 4.5 x 30mm; 320-20-26, 5252896, compression screw, 4.5 x 26mm.
Event or Problem Description
Revision due to failed anatomic shoulder.Patient was experiencing unexplained pain.
Additional Manufacturer Narrative
Section h10: (d4) expiration date: 23-mar-2027.(h3) equinoxe reverse in place.Patient experienced unexplained shoulder pain, surgeon revised stem and glenospher and removed 3 screws there is no indication that there was a malfunction with the device, the most likely cause of the rotator cuff injury is related to the patient condition.Equinoxe is intended for individuals who have degenerative disease of the shoulder.Product was not returned.No additional information provided.Section(s): no information provided: a2, a3, a5, b6, b7, d6, e3, g4, g5, g8, h4.Section h11: corrections made in the following section(s): (g4) (b)(6) 2019.

• Brand Name: EQUINOXE
• Common Device Name: 36MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8821719
• Report Number: 1038671-2019-00373
• Device Sequence Number: 16921406
• Product Code: KWT
• UDI-Device Identifier: 10885862086372
• UDI-Public: 10885862086372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 320-01-36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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