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

Catalog Number	314-02-14
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Medical device site infection (4845)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported the need for a revision approximately 15 years after initial tsa performed in 2009 through the ethics hotline.Since the initial replacement, the patient has experienced pain and infection.A revision was scheduled for september after a surgeon confirmed there was loose plastic in the shoulder.
Additional Manufacturer Narrative
D10: concomitants: 1481661 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.1522617 300-10-45 - equinoxe replicator plate 4.5mm o/s.1503126 300-20-02 - equinox square torque define screw drive kit.1400079 310-01-50 - equinoxe, humeral head short, 50mm (beta).
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-1405-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d6b, h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported may be the result of prosthesis wear, infection, and/or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were 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 GLENOID, PEGGED BETA, LARGE
• 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 66 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19680105
• Report Number: 1038671-2024-02305
• Device Sequence Number: 16946828
• Product Code: HSD
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 08/03/2014
• Device Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2009
• 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 Sex: Unknown