MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number HUMERAL HEAD SHORT, 50MM (BETA)

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 300-21-00 - 0mm fixed angled kit 7195549.304-21-13 - 12.5mm platform fx stem left 6715604.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 51 year-old male patient who had an initial left shoulder arthroplasty on (b)(6) 2022, was revised on (b)(6) 2023, approximately 10 months post the initial procedure.The revision procedure was for failed rotator cuff in l) hemi-arthroplasty, performed for proximal humeral fracture in 2022.All components were revised and converted to a reverse total shoulder replacement using equinoxe system.No surgical delays reported.Patient was last known to be in stable condition following the event.No device returns anticipated.The implants were required for collection of infected materials and were sent to hospital pathology.No further information.

Manufacturer Narrative

H6: upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or instability of total joint hardware.The most likely cause of the reported event is the patient¿s activity and the surgeon¿s choice of initial implant.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 16556690
• MDR Text Key: 311479617
• Report Number: 1038671-2023-00451
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042021
• 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: 07/05/2023

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: HUMERAL HEAD SHORT, 50MM (BETA)
• Device Catalogue Number: 310-01-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 90 KG