MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-01-38

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

Patient Problem Implant Pain (4561)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.320-38-00 - equinoxe reverse 38mm humeral liner +0.320-10-00 - equinoxe reverse tray adapter plate tray +0.

Event Description

It was reported via clinical study that the patient experienced a breakage of a component, causing a slow onset deep shoulder ache.It was initially considered to be an acromial stress fracture but x-ray and ct-scan confirmed broken glenoid screw and loosening of glenosphere.The date of event onset is (b)(6) 2020.The patient was revised on (b)(6) 2021.There were attempts to contact the patient the outcome was last known as resolved on (b)(6) 2022.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of the glenoid baseplate not achieving long-term fixation, causing a compression screw to bear the joint load and eventually fracture.However, this cannot be confirmed as the devices were not returned for evaluation and adequate information was not provided to confirm the failure and evaluate the root cause of the screw breakage.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported via clinical study that the patient experienced a breakage of a component, causing a slow onset deep shoulder ache.It was initially considered to be an acromial stress fracture but x-ray and ct-scan confirmed broken glenoid screw and loosening of glenosphere.The date of event onset is 12-08-2020.The patient was revised on (b)(6) 2021.There were attempts to contact the patient the outcome was last known as resolved on (b)(6) 2022.The case report form indicates this event is definitely related to device and unlikely related to procedure.(d1) brand name: equinoxe reverse 38mm glenosphere.(h6) component code: 568, screw.

Event Description

It was reported via clinical study that the patient experienced a breakage of a component, causing a slow onset deep shoulder ache.It was initially considered to be an acromial stress fracture but x-ray and ct-scan confirmed broken glenoid screw and loosening of glenosphere.The date of event onset is 12-08-2020.The patient was revised on (b)(6) 2021.There were attempts to contact the patient the outcome was last known as resolved on (b)(6) 2022.The case report form indicates this event is definitely related to device and unlikely related to procedure.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• 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: 17098866
• MDR Text Key: 316941413
• Report Number: 1038671-2023-01305
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• 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,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention