MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE LASER CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-23-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Concomitants: (b)(6) 300-60-02 - stemless humeral comp laser cage size 2.(b)(6) 310-62-41 - stemless humeral head 41mm x 13mm x alpha.(b)(6) 314-23-02 - laser cage glenoid small alpha.(b)(6) 319-01-32 - steinmann pin sterile 3.2mm x 178mm (b)(6) 321-52-07 - 3.2mm drill bit sterile.
Event or Problem Description
As reported, approximately 1 year and 1 month post initial right total shoulder arthroplasty (tsa), revision was performed due to glenoid loosening and radiolucency around the center cage.All components were removed (stemless humeral component, humeral head, and laser cage glenoid).A central screw baseplate was re-implanted with 36mm glenosphere.On the humeral side, the surgeon implanted a 10mm standard stem with +0 tray and +2.5mm liner.The event was unrelated to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE LASER CAGE GLENOID SMALL, ALPHA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 21148872
• Report Number: 1038671-2025-00233
• Device Sequence Number: 9134526
• Product Code: KWS
• UDI-Device Identifier: 10885862585288
• UDI-Public: 10885862585288
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K212356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 314-23-02
• 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: 12/31/2024
• Initial Report FDA Received Date: 01/14/2025
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female