MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER COMPONENTS; SEE H10

Model Number	EQUINOXE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained.D10: concomittants: 300-62-01 stemless humeral comp integrip, cage, size 1.Cage glenosphere.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a female patient underwent a shoulder revision of the right shoulder.Initial implant date and explant date unknown.Dr.Noel removed a stemless anatomic total shoulder and replaced with an arthrex reverse glenoid baseplate that included a 6.5 mm central screw, and arthrex glenosphere, an exactech preserve stem, and an exactech zero tray and exactech liner.There were no surgical delays or device breakages.No x-rays or device images were provided.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as the facility held the explanted devices.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues of the stemless humeral head extra short device, reason for revision is not reported.The cause of the shoulder revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d1, d4, d10, g4, h6, h11.D10: 310-60-47 stemless humeral head extra short, 47mm (beta).300-62-01 stemless humeral comp integrip, cage, size 1.Cage glenosphere.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.

• Brand Name: EQUINOXE SHOULDER COMPONENTS
• Common Device Name: SEE H10
• 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: 16931139
• Report Number: 1038671-2023-00991
• Device Sequence Number: 6841275
• Product Code: PKC
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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 Model Number: EQUINOXE
• Device Catalogue Number: 310-60-47
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 04/21/2026
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 12/11/2023; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 184 LB