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

Model Number GLENOSPHERE 38MM

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

Patient Problem Unspecified Infection (1930)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: (b)(4), 300-30-07 - equinoxe preserve stem 7mm, (b)(6) 2021; (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6) 2021; (b)(4), 320-15-04 - rs glenoid plate r post aug, 8 deg, right, (b)(6) 2021; (b)(4), 320-15-05 - eq rev locking screw, (b)(6) 2021; (b)(4), 320-20-00 - eq reverse torque defining screw kit, (b)(6) 2021; (b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6) 2021; (b)(4), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, (b)(6) 2021; (b)(4), 320-38-00 - 145-deg pe 38mm hum liner +0, (b)(6) 2021; (b)(4), 531-78-20 - shouldr gps hex pins kit, (b)(6) 2021.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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Infection is a clinically well-known potential complication of any surgical procedure including shoulder arthroplasty.

Event Description

It was reported that a 65 yo male patient, had an initial right shoulder implanted on (b)(6)2021, and then underwent a revision procedure on (b)(6) 2022, approximately 1 year 4 months post the initial procedure.The patient had a suspected infection.I&d was done and liner and glenosphere were replaced.The patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation during the revision procedure.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.The devices will not to be returned due to hospital policy.No additional information.

• 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: kate jacobson ; 3523771140
• MDR Report Key: 16195962
• MDR Text Key: 307605557
• Report Number: 1038671-2023-00043
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862563699
• UDI-Public: 10885862563699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOSPHERE 38MM
• Device Catalogue Number: 320-06-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Date Device Manufactured: 06/22/2021
• 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: 65 YR
• Patient Sex: Male