MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	310-03-53
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fistula (1862); Joint Dislocation (2374); Subluxation (4525); Joint Laxity (4526)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-10-45 - equinoxe replicator plate 4.5mm o/s: a188948; 300-20-02 - equinox square torque define screw drive kit: a090781, 321-20-00 - equinoxe reverse shoulder drill kit: a181278.(h3) pending evaluation.
Event or Problem Description
As reported by the equinoxe shoulder study, the 64-year-old male patient had a left tsa on (b)(6) 2022.The patient presented with a instability / subluxation on (b)(6) 2023.Shoulder continued to subluxate post-operatively, especially at night.Patient also developed a fistula and a draining sinus.This event is related to (b)(4).The outcome of this event is considered resolved on (b)(6) 2023 by the action of revision.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
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, e, g.The reason for the reported revision due to subluxation and instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, rotator cuff failure, patient anatomy, implant positioning, and/or implant selection.Subluxation and instability are known risks, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19009221
• Report Number: 1038671-2024-00693
• Device Sequence Number: 20943708
• Product Code: HSD
• UDI-Device Identifier: 10885862083999
• UDI-Public: 10885862083999
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Study,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 310-03-53
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 03/30/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White