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

Catalog Number	314-01-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had a loose cemented keeled glenoid removed and replaced with a competitor's vrs implant.The head and replicator plate were also removed and replaced with a +5 tray and a 40+0 liner.The stem was well fixed and left in place.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: 1.5mm replicator plate (cat #: 300-10-15).Equinoxe, humeral head tall, 41mm (alpha) (cat #: 310-02-41).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, d6a, g3/g4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision may have been due to wear on the articular surface on the glenoid from use over time, patient-related factors, and/or overstuffing of the joint.Additionally, an insufficient bond between the glenoid component and the bone leading to aseptic (non-infected) glenoid loosening could have contributed to the revision.However, the glenoid loosening and the cause of the wear cannot be confirmed from the provided information.Potential user and patient-related considerations to the event could not be assessed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3 (remove erroneous date from initial report-unknown) h6 clinical code.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE GLENOID, KEELED 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19415488
• Report Number: 1038671-2024-01538
• Device Sequence Number: 19643182
• Product Code: HSD
• UDI-Device Identifier: 10885862084408
• UDI-Public: 10885862084408
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

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: 04/23/2016
• Device Catalogue Number: 314-01-02
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 04/21/2025; 11/20/2025
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 04/22/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female