MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 320-10-05 equinoxe reverse tray adapter plate +5mm (b)(6).320-38-03 145 degree 38mm humeral liner +2.5 s395220.300-01-10 equinoxe humeral stem 10mm primary (b)(6).320-15-02 rs glenoid plate sup.Aug 10 deg.(b)(6).320-06-38 equinoxe 38mm glenoshere.320-20-30 eq rev compression screw w/ cap 4.5 x 30mm (b)(6).320-20-30 eq rev compression screw w/ cap 4.5 x 30mm (b)(6).320-15-05 eq rev locking screw (b)(6).
Event or Problem Description
As reported, approximately 1 month and 9 days post the first revision surgery, the patient presented back with continued issues with instability and pain.The patient underwent a second revision.The surgeon had issues with being able to get the torque screw out of the humeral stem and tray.It was not fully released from the stem, causing the humeral tray to spin circumferentially around the stem.The surgeon replaced the glenosphere with a lateralized one, kept the tray as it would not release from the stem, and implanted a constrained liner.There was a 5-15 minute delay.The patient did not experience any adverse events as a result of the delay.The surgeon felt he got a stable construct with the implants that he was able to exchange.He would have liked to be able to release the humeral tray from the humeral stem and spent some time trying to disengage the implants however was not able to get them to disengage.The patient was last known to be in stable condition following the event.
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: b, c, d.The reason for the revision reported may have been due to instability.However, the underlying cause of the instability cannot be determined from the limited information provided.The inability to remove the torque defining screw from the humeral stem may have been due to possible thread damage.However this could not be confirmed because the components remain implanted and no images or radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20632441
• Report Number: 1038671-2024-04305
• Device Sequence Number: 20697605
• Product Code: HSD
• UDI-Device Identifier: 10885862283009
• UDI-Public: 10885862283009
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 300-01-10
• 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: 10/27/2024
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 05/09/2019
• 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
• Patient Age: 77 YR
• Patient Sex: Female