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

Catalog Number	320-38-03
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, the 70-year-old male patient had an initial left tsa on (b)(6) 2023 and presented with instability/subluxation, approximately 2 month(s) and 0 year(s) post-operatively on (b)(6) 2023.Patient reached over shoulder to buckle seatbelt on (b)(6) 23 and had a subluxation incident.Second subluxation occurred in (b)(6) 2023 after carrying a 10 lb box.The outcome of this event is considered continuing, and no action was taken.The case report form indicates that this event is possibly related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 320-06-38 - glenosphere 38mm: a042835 300-30-07 - equinoxe preserve stem 7mm: a262915 320-10-00 - equinoxe reverse tray adapter plate tray +0: a488094 320-15-01 - eq rev glenoid plate: a273994 320-15-05 - eq rev locking screw: a375383 320-20-00 - eq reverse torque defining screw kit: a424139 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: s424777 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: a172579 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: a344721 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: s425113.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d1, d4, g4, h6, h11.The following sections were corrected: h6.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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 SHOULDER SYSTEM
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18791697
• Report Number: 1038671-2024-00330
• Device Sequence Number: 18230528
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 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: 01/29/2024
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White