MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): eq rev compress screw lck cap kit, 4.5 x 22mm, 320-20-22, (b)(6).Eq rev compress screw lck cap kit, 4.5 x 30mm, 320-20-30, (b)(6).Eq rev compress screw lck cap kit, 4.5 x 26mm, 320-20-26, (b)(6).Eq rev compress screw lck cap kit, 4.5 x 26mm, 320-20-26, (b)(6).Eq rev glenoid plate, 320-15-01, (b)(6).Equinoxe reverse 38mm humeral liner +0, 320-38-00, (b)(6).Equinoxe reverse tray adapter plate tray +0, 320-10-00, (b)(6).Eq reverse torque defining screw kit, 320-20-00, (b)(6).Eq rev locking screw, 320-15-05, (b)(6).Equinoxe reverse 38mm glenosphere, 320-01-38, (b)(6).Eq rev compress screw lck cap kit, 4.5 x 18mm, 320-20-18, (b)(6).
Event or Problem Description
As reported, approximately 6 months post op initial right tsa, this 56 y/o male patient was revised due to instability.Second stage process.Everything was removed.Patient was last known to be in stable condition following event.Product not returning: disposed at the hospital.Unable to obtain images or x-rays.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17681955
• Report Number: 1038671-2023-02144
• Device Sequence Number: 2558556
• Product Code: KWT
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• 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 Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 300-01-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male