MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REPLICATOR PLATE 1.5MM O/S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REPLICATOR PLATE 1.5MM O/S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6) ) - equinoxe, humeral head short, 41mm (alpha) (cat# 310-01-41 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine months post initial left tsa, the 64 y/o male patient had a stage 2 revision as planned by the surgeon.Patient had a weak bone.Surgeon inserted a hemi plus a bone graft in the last revision.Surgeon removed the glenoid bone graft and inserted a reverse shoulder.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation as they were disposed by the hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2022-00959.

• Brand Name: EQUINOXE REPLICATOR PLATE 1.5MM O/S
• Common Device Name: PROSTHESIS, SHOULDER, NON-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: kate jacobson ; 3523771140
• MDR Report Key: 17651974
• Report Number: 1038671-2023-02101
• Device Sequence Number: 6331683
• Product Code: KWT
• UDI-Device Identifier: 10885862079381
• UDI-Public: 10885862079381
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 06/03/2025
• Device Model Number: EQUINOXE REPLICATOR PLATE 1.5MM O/S
• Device Catalogue Number: 300-10-15
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male