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

Model Number	EQUINOXE CAGE GLENOID SMALL, ALPHA
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 64 year old female patient had an initial right tsa on (b)(6) 2020.The patient was revised on (b)(6) 2024 due to poly failure.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos & x-rays received.The devices are not available for evaluation due to chain of command.
Additional Manufacturer Narrative
Section d10: concomitant products: - equinoxe, humeral stem primary, press fit 9mm (cat# 300-01-09 / serial# (b)(6)).- equinoxe replicator plate 4.5mm o/s (cat# 00-10-45 / serial# (b)(6)).- equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6)).- equinoxe, humeral head short, 38mm (alpha) (cat# 310-01-38 / serial# (b)(6)).- equinoxe cage glenoid small, alpha (cat# 314-13-02 / serial# (b)(6)).- glnd kwire (cat# 315-35-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision was likely because of the glenoid component migrating from its intended location due to cage fracture and loosening.However, the potential cause of the failure and the sequence of events cannot be confirmed as the device was not returned for evaluation.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code and problem code.

• Brand Name: EQUINOXE 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 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19038390
• Report Number: 1038671-2024-00734
• Device Sequence Number: 15462934
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 05/05/2024
• Device Model Number: EQUINOXE CAGE GLENOID SMALL, ALPHA
• Device Catalogue Number: 314-13-02
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• 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: GPS IMPLANT KIT V2; SHOULDR GPS HEX PINS KIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female