MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
7033170 - 300-30-11 - equinoxe preserve stem 11mm a149071 - 320-06-42 - glenosphere 42mm a135617 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 a163013 - 320-15-05 - eq rev locking screw 6144875 - 320-15-07 - sup/post aug plate, l rs glenoid baseplate a124848 320-20-00 - eq reverse torque defining screw kit a166821 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm a039019 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm a141012 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm 6029281 - 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm 6097913 - 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm s336228 - 320-42-00 - 145-deg pe 42mm hum liner +0 (b)(6) - 320-42-13 - 145-deg pe 42mm const hum liner +2.5.
Event or Problem Description
It was reported that a 81 yo male patient, initial left shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2024, approximately 1 year 5 months post the initial procedure.The patient presented with complaints of pain.Bad poly indicated.The poly was replaced.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The patient was last known to be in stable condition following the event.The explanted device is not available for return.Chain of command, due to the recall the hospital will not release it.A device image was provided.No further information.No other patient information/medical history reported.
Event or Problem Description
It was reported that a 81 yo male patient, initial left shoulder implanted and then underwent a revision procedure, approximately 1 year 5 months post the initial procedure.The patient presented with complaints of pain.Bad poly indicated.The poly was replaced.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The patient was last known to be in stable condition following the event.The explanted device is not available for return.Chain of command, due to the recall the hospital will not release it.A device image was provided.No further information.No other patient information/medical history reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a, h6.Mdr section codes updated/corrected: b, c, d, e.The revision reported was likely the result of prosthesis wear on the rim of the humeral liner, which may have been due to scapular notching.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE 42MM 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153302
• Report Number: 1038671-2024-00920
• Device Sequence Number: 20943839
• Product Code: KWT
• 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: 2022
• 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): 10/27/2025

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: 08/05/2024
• Device Catalogue Number: 320-42-13
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2019
• 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 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 81 KG