MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number NK

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

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported via an equinoxe shoulder clinical study, that an 83 yo female patient, who had an initial shoulder implanted on (b)(6) 2016, presented with a history of increasing pain, date of event onset was march 29, 2022.X-rays demonstrated significant humeral loosening with possible calcar periprosthetic fracture as the cause.There was no action taken.The patient was due to have a revision of the humeral stem but repeat radiographs demonstrated that the humerus had stabilized itself and the patient's symptoms had resolved on (b)(6) 2022.The study indicates it was possibly related to the devices, and definitely related to the procedure.No further information.

Manufacturer Narrative

D10: concomittants: reverse humeral liner.Reverse humeral tray.Reverse humeral tray (extension).Reverse glenosphere.Reverse glenosphere baseplate.Humeral reconstruction prosthesis.

Manufacturer Narrative

H3: the humeral loosening reported may have been a result of the suspected periprosthetic fracture.Ultimately, this was reported to have resolved itself prior to surgical intervention.This cannot be confirmed as radiographs were not provided for review.

• Brand Name: EQUINOXE
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19126628
• MDR Text Key: 340403399
• Report Number: 1038671-2024-00895
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2024

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: NK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2023
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 07/10/2024
• Supplement Dates FDA Received: 07/18/2024
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White