MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Radiation Burn (1755); Unspecified Infection (1930)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 months post op the initial left tsa, this 66 y/o male patient was revised due infection.No breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos attached, unable to obtain x-rays.Product not returning - surgeon took it.
Additional Manufacturer Narrative
Device pending evaluation.Concomitant device(s): a128631 300-01-11 - equinoxe, humeral stem primary, press fit 11mm; a046605 320-10-00 - equinoxe reverse tray adapter plate tray +0; 7295094 320-15-01 - eq rev glenoid plate; a117518 320-15-05 - eq rev locking screw; a122310 320-20-00 - eq reverse torque defining screw kit; a156946 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; a157078 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; s368394 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; a118401 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; a141088 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; a123385 320-42-00 - equinoxe reverse 42mm humeral liner +0; 6929600 321-20-00 - equinoxe reverse shoulder drill kit; a010819 321-52-09 - 3.2mm k-wire, trocar tip; a010928 321-52-09 - 3.2mm k-wire, trocar tip.
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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• 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: 16723646
• Report Number: 1038671-2023-00655
• Device Sequence Number: 7292870
• Product Code: KWT
• 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: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 05/11/2026
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/06/2023; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 264 LB