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

Catalog Number	314-13-14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Implant Pain (4561)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by medwatch report (b)(4), approximately 5 years and 9 months post the initial left total shoulder arthroplasty, the patient reported worsening left shoulder pain.A ct scan revealed post-surgical changes concerning for osteolysis about the glenoid and proximal humeral prosthetic components.It also demonstrated a super imposed pathologic fracture of the glenoid.The explanted devices are currently in the lab for tissue exam.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Additional Manufacturer Narrative
Medwatch report (b)(4) this follow-up report is being submitted to relay corrected information.The following sections were corrected: removed information provided in b5 and added to h10, g2.
Additional Manufacturer Narrative
The pain reported may be the result of the glenoid fracture and osteolysis as reported.The glenoid was reported to be fractured but radiographs and images were not available.Contributing factors to the reported fracture may include a combination of articular surface wear and thinning of the glenoid body, incomplete seating, and/or eccentric loading around a well-fixed center cage with loosening of the peripheral pegs may have led to the fracture but this cannot be confirmed from the information provided.Potential contributions of manufacturing, patient, or user-related issues to the event cannot be determined from the reported information.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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: 21108350
• Report Number: 1038671-2025-00163
• Device Sequence Number: 8067941
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2023
• Device Catalogue Number: 314-13-14
• 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: 12/21/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 04/11/2025; 05/19/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/14/2025; 04/11/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White