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

Model Number EQUINOXE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/17/2023

Event Type  Injury  

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 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.

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.

• Brand Name: EQUINOXE
• Type of Device: 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
• MDR Text Key: 315210798
• Report Number: 1038671-2023-00991
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10885862537058
• UDI-Public: 10885862537058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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 Operator: 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
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 84 KG