MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 10 months, a patient had a revision due to liner association.There was no additional injury ot the patient.Patient revised to exactech devices: liner and adapter tray were exchanged.Patient was last known to be in stable condition following the event.Related to 1038671-2023-01003 (right side - revision 1).
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 315-35-00 - glnd kwire, (b)(6), 320-01-46 - equinoxe reverse 46mm glenosphere, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of disassembly between the humeral liner and humeral tray.However, this cannot be confirmed and potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs were not provided.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL CONST LINER +2.5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19909201
• Report Number: 1038671-2024-02680
• Device Sequence Number: 7136351
• Product Code: KWT
• UDI-Device Identifier: 10885862086761
• UDI-Public: 10885862086761
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2025
• Device Catalogue Number: 320-46-13
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 91 KG