MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-03
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 months post op initial left tsa, this 82 y/o male patient was revised due to an infection.All reverse implants were removed & shoulder spacer left in ( 48 - fortcem spacer provided by exactech).Patient was last known to be in stable condition following the event.No other patient information/medical history provided.Photo attached.Unable to obtain x-rays.Device is not returning.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6): 315-35-00 - glnd kwire, (b)(6): 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6): 320-15-04 - rs glenoid plate post aug, 8 deg, right, (b)(6): 320-15-05 - eq rev locking screw,, (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): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6): 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of infection.The cause of surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The wear noted on the image of the explanted humeral liner is likely the result of impingement with the scapula.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17757239
• Report Number: 1038671-2023-02284
• Device Sequence Number: 15206365
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• 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): 11/13/2024

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: 320-38-03
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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 H10.
• Patient Age: 82 YR
• Patient Sex: Male