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

Model Number EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA)

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 4934156 314-13-14 - equinoxe cage glenoid large, beta, 5161555 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, 5348703 300-50-45 - 4.5mm short rep plate.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported via an equinoxe clinical shoulder study, that a 69 yo male patient, who had an initial shoulder implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2023, approximately 5 years post the initial procedure.The patient presented with increased pain and limited function due to aseptic humeral and glenoid loosening.Date of onset was (b)(6) 2023.The patient underwent a revision sx; tsa to rtsa.The study indicates that the event was possibly related to the devices and the procedure.The outcome indicates the incident was resolved on (b)(6) 2023.No device returns anticipated due to study guidelines.No further information.

• 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: 17744148
• MDR Text Key: 323382903
• Report Number: 1038671-2023-02263
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• 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,Company Representative
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA)
• Device Catalogue Number: 310-01-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/14/2023
• Date Device Manufactured: 10/27/2017
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White