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

Model Number EQUINOXE REVERSE 38MM GLENOSPHERE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: equinoxe, humeral stem primary, press fit 11mm (cat# 300-01-11); equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00); equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00); rs glenoid plate ext cag +10mm cage peg (cat# 320-15-06).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the equinoxe shoulder study, approximately seven months post initial tsa, the 87 y/o female patient felt sudden increase in pain and felt a crack.The event was resolved on (b)(6) 2022.Per clinical study case report form indicates this event is possibly related to devices and procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported by the equinoxe shoulder study, approximately seven months post initial right reverse tsa for osteoarthritis, the 87 y/o female patient felt sudden increase in pain and felt a crack due to a scapular fracture.The event was resolved on (b)(6) 2022.Per clinical study case report form indicates this event is possibly related to devices and procedure.This event report was received through clinical data collection activities.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying conditions and scapular fracture.These devices are used for treatment not diagnosis.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15198504
• MDR Text Key: 297596242
• Report Number: 1038671-2022-00905
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White