MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	310-01-44
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years after the initial left tsa, the 68-year-old female patient was revised on (b)(6) 2024 due to increased pain in her shoulder within the last year.Once the incision was made, the surgeon noticed some black bubbles surrounding the sutures.Once we got a little deeper, the humeral head was removed along with the replicator plate and screw.The surgeon decided to leave the stem alone and move on to removing the caged glenoid.He was able to remove it with just the suction catheter as it had snapped from the cage.Cage was removed with threaded cage extractor on a slap hammer.There was a lot of glenoid bone loss and medialization.Our extended cage implant was used along with our screws and a 36mm +4mm lateralized glenosphere.Our trials were spinning on the stem implant that was left in place when trailing the liner and tray.We opened up implants and they were spinning as well on the stem implant.Because of this we were not able to implant them due to the threads being damaged in the preserve stem.Preserve stem was explanted and the surgeon used a competitor device for the humeral side.All parts and pieces were removed from the wound site.There was a 30-45 minute delay and the patient did not experience any adverse events as a result.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitant devices: (b)(6), 314-13-02 - equinoxe cage glenoid small, alpha.(b)(6), 300-30-11 - equinoxe preserve stem 11mm.(b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 300-20-02 - equinox square torque define screw drive kit.

• Brand Name: EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville 32653
• MDR Report Key: 22522652
• Report Number: 1038671-2025-02505
• Device Sequence Number: 15591267
• Product Code: HSD
• UDI-Device Identifier: 10885862083876
• UDI-Public: 10885862083876
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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 Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2024
• Initial Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 11/21/2019
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female