MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID M, POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation d10: 6384622 300-62-01 - stemless humeral comp integrip, cage, size 1; 6428952 310-62-44 - stemless humeral head 44mm x 14mm x beta.
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2020.The patient presented on (b)(6) 2022 and began having pain in (b)(6) 2022; no injury.The patient was revised (b)(6) 2023.The case report form indicates that this event is definitely not related to device, definitely not related to procedure.Outcome: resolved on (b)(6) 2023.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The pain reported may be the result of the glenoid loosening as reported.However, the failure cannot be confirmed as no relevant clinical information, images, or radiographs were provided.Potential contributions of manufacturing, patient, or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• 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: kate ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17780978
• Report Number: 1038671-2023-02322
• Device Sequence Number: 6551542
• Product Code: KWS
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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
• Device Expiration Date: 04/02/2024
• Device Model Number: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• Device Catalogue Number: 314-13-33
• 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: 09/17/2023
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2019
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White