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

Catalog Number	320-38-03
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op initial right tsa, this 68 y/o female patient's right knee was revised due to instability.Glenoshere, locking screw , liner , adapter tray and torque screw were changed.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain x-rays/photos.Product not returning - disposed by hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 4889713 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.4804237 315-35-00 - glnd kwire.4917471 315-35-00 - glnd kwire.5068769 320-01-38 - equinoxe reverse 38mm glenosphere.5092937 320-10-00 - equinoxe reverse tray adapter plate tray +0.5014300 320-15-04 - rs glenoid plate post aug, 8 deg, right.4957307 320-15-05 - eq rev locking screw.5075494 320-20-00 - eq reverse torque defining screw kit.4923453 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.4988872 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.5012648 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.4550033 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.8011017076 a10012 - gps implant kit v2.
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 instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Event or Problem Description
As reported, approximately 5 years post op initial right tsa, this 68 y/o female patient's right shoulder was revised due to instability.Glenoshere, locking screw , liner , adapter tray and torque screw were changed.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain x-rays/photos.Product not returning - disposed by hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5 (correcting typo of knee to shoulder), d1, d4 (remove all from initial report-suspect device unknown), d8, g4 (remove 501k from initial report-unknown), h4 (remove erroneous date from initial report), h6: clinical code, medical device problem code, investigations: type, findings and conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16910094
• Report Number: 1038671-2023-00965
• Device Sequence Number: 7205898
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2022
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 10/20/2025
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female