MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; UHMWPE POST AUG GLENOID LARGE, RIGHT

Model Number	314-02-34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision due to poly wear.
Event or Problem Description
Revision due to possible poly wear, reason not reported.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of a weak rotator cuff, glenoid loosening, prosthesis wear, or a combination of the three.However, this cannot be confirmed as the other explanted devices were not returned, and no information regarding the reason for revision was provided.Section h11: *the following sections have corrected information: (b5) revision due to possible poly wear, reason not reported.(d10) yes.*no information provided in the following section(s): a2, a3, a4, a5, b6, b7, d6, d7, d11, g8, h4, h7, h9.

• Brand Name: EQUINOXE
• Common Device Name: UHMWPE POST AUG GLENOID LARGE, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9156153
• Report Number: 1038671-2019-00484
• Device Sequence Number: 19535873
• Product Code: KWT
• UDI-Device Identifier: 10885862175113
• UDI-Public: 10885862175113
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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 Model Number: 314-02-34
• Device Catalogue Number: 314-02-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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