MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED ALPHA, SMALL; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	314-02-02
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: 2906382 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 2817355 300-10-45 - equinoxe replicator plate 4.5mm o/s 2762404 300-20-02 - equinox square torque define screw drive kit 2836834 300-20-02 - equinox square torque define screw drive kit 2159816 310-02-44 - equinoxe, humeral head tall, 44mm (alpha) 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.
Event or Problem Description
It was reported that this patient's atsa (anatomic total shoulder arthroplasty) was revised to a rtsa (reverse total shoulder arthroplasty) approximately 11 years 6 months post initial operation.The photos provided show signs of wear.Patient was last known to be in stable condition following the event.No further information available.

• Brand Name: EQUINOXE GLENOID, PEGGED ALPHA, SMALL
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22945884
• Report Number: 1038671-2025-02865
• Device Sequence Number: 9783518
• Product Code: HSD
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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 Expiration Date: 07/29/2017
• Device Catalogue Number: 314-02-02
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 07/31/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male