MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 7MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-07
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year and 1 month post the initial right reverse total shoulder arthroplasty, the patient presented with pain.The patient is an amputation patient and has no legs.The surgeon suspected he had applied to much pressure to his shoulders.The liner was exchanged.A preserve stem was previously used, which had moved slightly into varus.The stem was very well fixed, so just the poly was revised.There was no issue with the poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No further information provided.
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.D10: (b)(6) a10012 - gps implant kit v2.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 300-30-08 - equinoxe preserve stem 8mm.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 300-30-07 - equinoxe preserve stem 7mm.(b)(6) 531-55-88 - ergo gps 3.2mm drill kit sterile.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 315-35-00 - glnd kwire.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 531-78-20 - shouldr gps hex pins kit.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11 the following sections were corrected: d1, d4, d10, g4, h4, h6 problem code, h6 component code d10: (b)(6) a10012 - gps implant kit v2 (b)(6) 320-38-00 - 145 deg pe 38mm hum liner +0 (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere (b)(6) 300-30-08 - equinoxe preserve stem 8mm (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 531-55-88 - ergo gps 3.2mm drill kit sterile (b)(6) 320-15-05 - eq rev locking screw (b)(6) 315-35-00 - glnd kwire (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6) 531-78-20 - shouldr gps hex pins kit (b)(6) 320-15-01 - eq rev glenoid plate (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm the reason for the pain and subsidence reported cannot be conclusively determined but may be related to an underlying patient condition, additional stresses on the shoulder secondary to manual wheelchair use, component sizing, positioning, impingement issues, or a combination of the above.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were provided.

• Brand Name: EQUINOXE PRESERVE STEM 7MM
• 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: 22017891
• Report Number: 1038671-2025-02060
• Device Sequence Number: 9484790
• Product Code: KWT
• UDI-Device Identifier: 10885862515759
• UDI-Public: 10885862515759
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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 Catalogue Number: 300-30-07
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male