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

Catalog Number 320-15-04

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: concomitants: 300-01-11 equinoxe, humeral stem primary, press fit 11mm.320-38-00 equinoxe reverse 38mm humeral liner +0.320-10-00 equinoxe reverse tray adapter plate tray +0.320-01-38 equinoxe reverse 38mm glenosphere.

Event Description

It was reported via clinical study, that the 73 yo female patient was experiencing aseptic glenoid loosening resulting in glenoid fracture or osteolysis.The date of event onset it (b)(6) 2023.The patient¿s standard reverse shoulder system was revised to hemiarthroplasty.The outcome was last known as resolved on (b)(6) 2023.

Manufacturer Narrative

H3: the revision reported was likely the result of loosening secondary to poor bone quality and fracture of the bone supporting the glenoid-side implant two months after the index procedure.However, this cannot be confirmed as the devices were not available for evaluation and no additional clinical information was provided.After further review the following has been corrected.H3: device was not returned or evaluated.

• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16762320
• MDR Text Key: 313523688
• Report Number: 1038671-2023-00719
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110708
• 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,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 85 KG