MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Catalog Number	320-02-42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-15-05, 4518795 - eq rev locking screw, 320-10-10, 2588450 - equinoxe reverse tray adapter plate tray +10, 320-20-00, 4867389 - eq reverse torque defining screw kit, 320-42-10, 4531704 - equinoxe reverse 42mm humeral const liner +0.
Event or Problem Description
The reason for the revision was not reported.Previous revision found for patient after receiving devices back from rep.Unable to obtain further details regarding this case.
Event or Problem Description
As reported, approximately 1.5 years postop the initial implant, this 66 y/o male patient was revised in (b)(6) 2019.Reason for revision was not reported.Event discovered in a recent complaint.Devices are not returning.No other information is patient conditions.
Additional Manufacturer Narrative
Section h10: (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 patient conditions.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, approximately 1.5 years postop the initial implant, this 66 y/o male patient was revised in (b)(6) 2019.Reason for revision was not reported.Event discovered in a recent complaint.Devices are not returning.No other information is patient conditions.

• Brand Name: EQUINOXE
• Common Device Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9340392
• Report Number: 1038671-2019-00572
• Device Sequence Number: 14005341
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 320-02-42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 08/26/2020
• 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 Age: 64 YR
• Patient Weight: 57