MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient, initial right shoulder implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2023, approximately 1 year 11 months post the initial procedure.The patient complained of pain.Infection and poly wear were reported.They were revised to a competitor¿s devices.There was no device breakage or surgical delays.The patient was last known to be in stable condition following the event.No x-ray were available.No device images were provided.The explanted devices are not available for return due to chain of command.Hospital will not release them.No further information.
Additional Manufacturer Narrative
D10: 300-01-13 - equinoxe, humeral stem primary, press fit 13mm (b)(6).300-10-45 - equinoxe replicator plate 4.5mm o/s (b)(6).310-01-44 - equinoxe, humeral head short, 44mm (alpha) (b)(6).314-13-33 - equinoxe cage glenoid m, post aug, right (b)(6).315-35-00 - glnd kwire (b)(6).531-78-20 - shouldr gps hex pins kit (b)(6).320-02-42 - rs expanded glenosphere 42mm, +4mm offset (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-15-05 - eq rev locking screw (b)(6).320-15-06 - rs glenoid plate ext cag +10mm cage peg (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).320-42-13 - equinoxe reverse 42mm humeral const liner +2.5 (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d4, d6a, g1, g4, h4, h6 mdr section codes updated/corrected: b, c, d, g the revision reported was likely the result of scapular notching leading to prosthesis wear of the humeral liner.A contributing factor to the reported pain may have been the result of the patient developing an infection.The extent and root cause of the prosthesis wear and the infection could not be determined as the devices were not returned for evaluation, and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a female patient, initial right shoulder implanted and then underwent a revision procedure approximately 1 year 11 months post the initial procedure.The patient complained of pain.Infection and poly wear were reported.They were revised to a competitor¿s devices.There was no device breakage or surgical delays.The patient was last known to be in stable condition following the event.No x-rays were available.No device images were provided.The explanted devices are not available for return due to chain of command.Hospital will not release them.No further information.

• Brand Name: 145-DEG PE 42MM CONST HUM LINER +2.5
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 ; 3523771140
• MDR Report Key: 16935348
• Report Number: 1038671-2023-01000
• Device Sequence Number: 7291101
• Product Code: KWS
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Expiration Date: 03/22/2022
• Device Model Number: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• Device Catalogue Number: 320-42-13
• Device Lot Number: UKN
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 03/23/2017
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female