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

Catalog Number	320-42-13
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years and 1 months following a revision of the right total shoulder arthroplasty (tsa), another revision surgery was performed due to dislocation.The patient's shoulder at some point became unstable again and dislocated.During the revision surgery, the liner was found to have dissociated from the tray and was no longer between the tray and sphere.Metallosis in the tissue was observed, as well as wear on the liner, tray and sphere.The glenosphere, locking screw, liner, reverse torque screw, and tray were swapped out and the patient was upsized to a 46 expanded glenosphere, 0mm 46mm constrained liner and 5mm tray.The event was not related to the breakage of a device.The event lead to a surgical delay/prolongation of approximately 30-45 minutes.The delay/prolongation was in reference to the need for revision surgery due to dislocation of the prosthesis and dissociation of the poly.There was an adverse event of metal on metal wear of the glenosphere and tray and the associated metallosis.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Conocmitants: 320-10-00 equinoxe reverse tray adapter plate tray +0 (b)(6); 320-06-42 - glenosphere 42mm (b)(6); 320-15-05 - eq rev locking screw (b)(6) (b)(6) - gps implant kit v2 04000521122 exc-eqrv38-us - orthosensor 38mm usa (b)(6); 300-30-10 - equinoxe preserve stem 10mm (b)(6); 320-15-02 - rs glenoid plate sup aug, 10 deg (b)(6); 531-20-00 - shldr gps rvrs drill kit (b)(6); 531-78-20 - shouldr gps hex pins kit (b)(6); 320-20-00 - eq reverse torque defining screw kit (b)(6); 320-38-00 - 145-deg pe 38mm hum liner +0 (b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6); 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6); 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d.The revision reported was likely due to disassembly of the humeral liner and tray leading to migration of the humeral liner and subsequent metal-on-metal articulation between unintended components.There appears to be damage to the humeral liner, but it is unclear if it occurred prior to or after the disassembly.The disassembly of the humeral liner and tray may have been the result of positioning of the shoulder components, scapular notching/impingement, and/or patient related factors however, contributions of shoulder instability, shoulder dislocation and patient-related issues to the sequence of events cannot be confirmed by the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE 145-DEG PE 42MM CONST HUM 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20823700
• Report Number: 1038671-2024-04569
• Device Sequence Number: 12716049
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 04/18/2023
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 04/20/2018
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 124 KG