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

Model Number	EQUINOXE REVERSE 38MM GLENOSPHERE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 4 months after a total shoulder replacement, the patient was revised due to infection.Everything was removed.The event is not related to the breakage of a device.The event did not lead to a surgical delay or prolongation.Patient was last known to be in stable condition following the event.This is the third revision of the patient's shoulder.Sales rep was unable to obtain images or x-rays.The devices are not returning as they were disposed.
Additional Manufacturer Narrative
Section d10: concomitant devices - equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)) - eq rev locking screw (cat# 320-15-05 / serial# (b)(6)) - eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) - equinoxe reverse 38mm humeral liner +2.5 (cat# 320-38-03 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Result of investigation: a review of the sterile certificates was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or a continuation of a previously reported infection.The following fields have been updated: d1: brand name.H6: component code, investigation codes.Corrected fields: please disregard all product information listed in previous report: d4: model number, catalog number, expiration date, serial number, and udi.G4: 510(k) number.H4: device manufacture date.Concomitants: a354332 320-01-38 - equinoxe reverse 38mm glenosphere.A796911 320-10-00 - equinoxe reverse tray adapter plate tray +0 a741400 320-15-05 - eq rev.Locking screw a702966 320-20-00 - eq reverse torque defining screw kit a254650 320-38-03 - equinoxe reverse 38mm humeral liner +2.5.

• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19645787
• Report Number: 1038671-2024-02229
• Device Sequence Number: 18080261
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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: 70 YR
• Patient Sex: Male