MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: reverse humeral liner (cat#: 320-36-00).Reverse humeral tray (cat#: 320-10-00).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the equinoxe shoulder study, approximately two years post initial tsa, the 66 y/o patient came in for follow up and showed signs of aseptic humeral loosening.Patient had a revision on (b)(6) 2022.Patient's standard humeral stem, humeral tray and humeral liner were revised.Per clinical report, the reported event is definitely related to the device and procedure.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• Type of Device: 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
• MDR Report Key: 17751612
• MDR Text Key: 323465538
• Report Number: 1038671-2023-02273
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862283009
• UDI-Public: 10885862283009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• Device Catalogue Number: 300-01-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: Black Or African American